Clinical trial NCT01782326: QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)
Official title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QVA149, FLAME( EFfect of Indacaterol Glycopyronium Vs Fluticasone salmeterol on COPD Exacerbations)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 3362
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Male or female adults aged ≥40 years
* Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011)
* Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)
* Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥25 and \< 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) \< 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol)
* A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics
* Patients taking stable COPD medication (at least 60 days) prior to day 28
* Patients with an mMRC grade of at least 2 at day 28

Exclusion Criteria:

* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
* Patients with Type I or uncontrolled Type II diabetes
* Patients with a history of long QT syndrome or whose QTc measured at day 28 (Fridericia method) is prolonged (\>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened
* Patients who have a clinically significant ECG abnormality prior to randomization. (These patients should not be re-screened)
* Patients who have a clinically significant laboratory abnormality at screening
* Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment
* Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded
* Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at both pre-randomization visits, with a resting ventricular rate \< 100/min. At screening the atrial fibrillation must be confirmed by central reading
* Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines, lactose or any of the other excipients of trial medication
* Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
* Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered
* Patients who have not achieved an acceptable spirometry results at screening in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria)
* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to screening
* Patients who develop a COPD exacerbation of any severity (mild/moderate/severe) between screening and treatment will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation
* Patients who have had a respiratory tract infection within 4 weeks prior to screening
* Patients who develop a respiratory tract infection between screening and prior to treatment will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection
* Patients requiring long term oxygen therapy prescribed for \>12 hours per day
* Patients with any history of asthma
* Patients with an onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
* Patients with a blood eosinophil count \> 600/mm3 at screening
* Patients with allergic rhinitis who use a H1 antagonist or intra-nasal corticosteroids intermittently (treatment with a stable dose or regimen is permitted)
* Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension)
* Patients with clinically significant bronchiectasis
* Patients with a diagnosis of α-1 anti-trypsin deficiency
* Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active
* Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
* Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. (Maintenance program is permitted.)
* Patients receiving any medications in the classes listed in the protocol
* Patients receiving any COPD related medications in the classes specified in the protocol must undergo the required washout period prior to screening and follow the adjustment to treatment program
* Use of other investigational drugs/devices (approved or unapproved) at the time of enrollment, or within 30 days or 5 half-lives of screening, whichever is longer
* Patients unable to use an electronic patient diary and EXACT pro diary
* Patients unable to use a dry powder inhaler device, Metered Dose Inhaler (MDI) or a pressurized MDI (rescue medication) or comply with the study regimen.

Primary outcomes:
measure: Rate of COPD Exacerbations
timeFrame: 52 weeks
Secondary outcomes:
measure: Time to First COPD Exacerbation.
timeFrame: 52 weeks
measure: Rate of Moderate to Severe COPD Exacerbations.
timeFrame: 52 weeks
measure: Time to First Moderate to Severe COPD Exacerbation.
timeFrame: 52 weeks.
measure: Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids
timeFrame: 52 weeks
measure: Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics
timeFrame: 52 weeks
measure: Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included.
timeFrame: 52 weeks
measure: Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days
timeFrame: 52 weeks
measure: Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids
timeFrame: 52 weeks
measure: Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics
timeFrame: 52 weeks
measure: Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization
timeFrame: 52 weeks
measure: Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days
timeFrame: 52 weeks
measure: Forced Expiratory Volume in 1 Second
timeFrame: Baseline, day 1 (30 min and one hour post dose)
measure: Forced Expiratory Volume in 1 Second
timeFrame: Baseline, 4 weeks
measure: Forced Expiratory Volume in 1 Second
timeFrame: Baseline, 12 weeks
measure: Forced Expiratory Volume in 1 Second
timeFrame: Baseline, 26 weeks
measure: Forced Expiratory Volume in 1 Second
timeFrame: Baseline, 38 weeks
measure: Forced Expiratory Volume in 1 Second
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h)
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Total St. George's Respiratory Questionnaire Score
timeFrame: Baseline, 4 weeks
measure: Change From Baseline in Total St. George's Respiratory Questionnaire Score
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Total St. George's Respiratory Questionnaire Score
timeFrame: Baseline, 26 weeks
measure: Change From Baseline in Total St. George's Respiratory Questionnaire Score
timeFrame: Baseline, 38 weeks
measure: Change From Baseline in Total St. George's Respiratory Questionnaire Score
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in the Number of Puffs of Rescue Medication
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol.
timeFrame: Baseline, 52 Weeks
measure: Change From Baseline in Forced Vital Capacity
timeFrame: 4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks
measure: Number of Patients With Adverse Events, Serious Adverse Events, and Death
timeFrame: 52 weeks of treatment + 30 days
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Lanus
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
state: Capital Federal
city: Concepcion del Uruguay
country: Argentina
facility: Novartis Investigative Site
state: Entre Ríos
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Salta
country: Argentina
facility: Novartis Investigative Site
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
state: Tyrol
city: Feldbach
country: Austria
facility: Novartis Investigative Site
city: Feldkirch
country: Austria
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Grieskirchen
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Thalheim bei Wels
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Wels
country: Austria
facility: Novartis Investigative Site
city: Gosselies
country: Belgium
facility: Novartis Investigative Site
state: BEL
city: Genk
country: Belgium
facility: Novartis Investigative Site
state: Limburg
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Erpent
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Gilly
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
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facility: Novartis Investigative Site
city: Leuven
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facility: Novartis Investigative Site
city: Liège
country: Belgium
facility: Novartis Investigative Site
city: Luxembourg
country: Belgium
facility: Novartis Investigative Site
city: Oostende
country: Belgium
facility: Novartis Investigative Site
city: Roeselare
country: Belgium
facility: Novartis Investigative Site
city: Turnhout
country: Belgium
facility: Novartis Investigative Site
city: Wavre
country: Belgium
facility: Novartis Investigative Site
city: Gabrovo
country: Bulgaria
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Ruse
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Novartis Investigative Site
city: Troyan
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Burlington
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Downsview
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mirabel
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-Charles-Borromée
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Quillota
country: Chile
facility: Novartis Investigative Site
city: Santiago
country: Chile
facility: Novartis Investigative Site
city: Santiago
country: Chile
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Guang Zhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Haikou
country: China
facility: Novartis Investigative Site
state: Hainan
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
state: Hebei
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Shengyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Guang Zhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Floridablanca
country: Colombia
facility: Novartis Investigative Site
state: Santander
city: Armenia
country: Colombia
facility: Novartis Investigative Site
city: Medellín
country: Colombia
facility: Novartis Investigative Site
city: Karlovac
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Benesov
country: Czech Republic
facility: Novartis Investigative Site
city: Cesky Krumlov
country: Czech Republic
facility: Novartis Investigative Site
city: Cvikov
country: Czech Republic
facility: Novartis Investigative Site
city: Jindrichuv Hradec III
country: Czech Republic
facility: Novartis Investigative Site
city: Liberec
country: Czech Republic
facility: Novartis Investigative Site
city: Melnik
country: Czech Republic
facility: Novartis Investigative Site
city: Olomouc
country: Czech Republic
facility: Novartis Investigative Site
city: Ostrava - Hrabuvka
country: Czech Republic
facility: Novartis Investigative Site
city: Ostrava
country: Czech Republic
facility: Novartis Investigative Site
city: Pardubice
country: Czech Republic
facility: Novartis Investigative Site
city: Prague 4
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 10
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 5
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 6 - Repy
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 6
country: Czech Republic
facility: Novartis Investigative Site
city: Strakonice
country: Czech Republic
facility: Novartis Investigative Site
city: Teplice
country: Czech Republic
facility: Novartis Investigative Site
city: Zatec
country: Czech Republic
facility: Novartis Investigative Site
city: Aalborg
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen NV
country: Denmark
facility: Novartis Investigative Site
city: Hellerup
country: Denmark
facility: Novartis Investigative Site
city: Hvidovre
country: Denmark
facility: Novartis Investigative Site
city: Næstved
country: Denmark
facility: Novartis Investigative Site
city: Roskilde
country: Denmark
facility: Novartis Investigative Site
city: Silkeborg
country: Denmark
facility: Novartis Investigative Site
city: Sønderborg
country: Denmark
facility: Novartis Investigative Site
city: Århus
country: Denmark
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: HUS
country: Finland
facility: Novartis Investigative Site
city: Jyvaskyla
country: Finland
facility: Novartis Investigative Site
city: Kuopio
country: Finland
facility: Novartis Investigative Site
city: Pori
country: Finland
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Angers
country: France
facility: Novartis Investigative Site
city: Beuvry
country: France
facility: Novartis Investigative Site
city: Briis Sous Forges
country: France
facility: Novartis Investigative Site
city: Cournonterral
country: France
facility: Novartis Investigative Site
city: Lyon cedex 04
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Nimes Cedex
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: St Genis des Fontaines
country: France
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
state: Baden-Württemberg
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Peine
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Koblenz
country: Germany
facility: Novartis Investigative Site
state: NRW
city: Cottbus
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Geesthacht
country: Germany
facility: Novartis Investigative Site
state: Schleswig Holstein
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Bad Woerishofen
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Delitzsch
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freudenberg
country: Germany
facility: Novartis Investigative Site
city: Gauting
country: Germany
facility: Novartis Investigative Site
city: Hagen
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover Münden
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Landsberg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Neu Isenburg
country: Germany
facility: Novartis Investigative Site
city: Neumünster
country: Germany
facility: Novartis Investigative Site
city: Oranienburg
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Prien a. Chiemsee
country: Germany
facility: Novartis Investigative Site
city: Ratingen
country: Germany
facility: Novartis Investigative Site
city: Reinfeld
country: Germany
facility: Novartis Investigative Site
city: Rüdersdorf
country: Germany
facility: Novartis Investigative Site
city: Schleswig
country: Germany
facility: Novartis Investigative Site
city: Schwabach
country: Germany
facility: Novartis Investigative Site
city: Solingen
country: Germany
facility: Novartis Investigative Site
city: Stade
country: Germany
facility: Novartis Investigative Site
city: Teuchern
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Warendorf
country: Germany
facility: Novartis Investigative Site
city: Weinheim
country: Germany
facility: Novartis Investigative Site
city: Wissen
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Larissa
country: Greece
facility: Novartis Investigative Site
state: GR
city: Rethymno
country: Greece
facility: Novartis Investigative Site
state: GR
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Heraklion Crete
country: Greece
facility: Novartis Investigative Site
city: Serres
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Ciudad
country: Guatemala
facility: Novartis Investigative Site
state: Gautemala
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Kowloon
country: Hong Kong
facility: Novartis Investigative Site
city: New Territories
country: Hong Kong
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Deszk
country: Hungary
facility: Novartis Investigative Site
city: Komarom
country: Hungary
facility: Novartis Investigative Site
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
city: Reykjavik
country: Iceland
facility: Novartis Investigative Site
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Vishakhapatnam
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Gurgaon
country: India
facility: Novartis Investigative Site
state: Haryana
city: Manipal
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Ludhiana
country: India
facility: Novartis Investigative Site
state: Punjab
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamilnadu
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Bangalore
country: India
facility: Novartis Investigative Site
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Cassano delle Murge
country: Italy
facility: Novartis Investigative Site
state: BA
city: Crema
country: Italy
facility: Novartis Investigative Site
state: CR
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: FG
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Pavullo nel Frignano
country: Italy
facility: Novartis Investigative Site
state: MO
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Cittadella
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Pordenone
country: Italy
facility: Novartis Investigative Site
state: PN
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: RE
city: Cuasso al Monte
country: Italy
facility: Novartis Investigative Site
state: VA
city: Tradate
country: Italy
facility: Novartis Investigative Site
state: VA
city: Negrar
country: Italy
facility: Novartis Investigative Site
state: VR
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Komaki-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Seto-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyoake-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Yanagawa-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Asahikawa-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Himeji-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Sakaide-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Takamatsu
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Koshi-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Matsusaka-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Sendai-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Kishiwada-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Koshigaya-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hamamatsu
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Iwata
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Meguro
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Kochi
country: Japan
facility: Novartis Investigative Site
city: Bucheon-Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-Do
city: Jeonju-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Alytus
country: Lithuania
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: México
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Guadalajara Jalisco
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site
city: Mexico D.F.
country: Mexico
facility: Novartis Investigative Site
city: Puebla
country: Mexico
facility: Novartis Investigative Site
city: Almelo
country: Netherlands
facility: Novartis Investigative Site
city: Assen
country: Netherlands
facility: Novartis Investigative Site
city: Breda
country: Netherlands
facility: Novartis Investigative Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
city: Geldrop
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Harderwijk
country: Netherlands
facility: Novartis Investigative Site
city: Zutphen
country: Netherlands
facility: Novartis Investigative Site
city: Follebu
country: Norway
facility: Novartis Investigative Site
city: Hønefoss
country: Norway
facility: Novartis Investigative Site
city: Kløfta
country: Norway
facility: Novartis Investigative Site
city: Kongsvinger
country: Norway
facility: Novartis Investigative Site
city: Skedsmokorset
country: Norway
facility: Novartis Investigative Site
city: Stavanger
country: Norway
facility: Novartis Investigative Site
city: Svelvik
country: Norway
facility: Novartis Investigative Site
city: Trondheim
country: Norway
facility: Novartis Investigative Site
city: Lipa City
country: Philippines
facility: Novartis Investigative Site
state: Batangas
city: Bulacan
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Pila
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Sopot
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Almada
country: Portugal
facility: Novartis Investigative Site
city: Barcelos
country: Portugal
facility: Novartis Investigative Site
city: Braga
country: Portugal
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Torres Vedras
country: Portugal
facility: Novartis Investigative Site
city: Vila Franca de Xira
country: Portugal
facility: Novartis Investigative Site
city: Vila Nova de Gaia
country: Portugal
facility: Novartis Investigative Site
city: Viseu
country: Portugal
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 3
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Dolj
city: Iasi
country: Romania
facility: Novartis Investigative Site
state: Jud. Iasi
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Arad
country: Romania
facility: Novartis Investigative Site
city: Arad
country: Romania
facility: Novartis Investigative Site
city: Brasov
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Cluj-Napoca
country: Romania
facility: Novartis Investigative Site
city: Deva
country: Romania
facility: Novartis Investigative Site
city: Deva
country: Romania
facility: Novartis Investigative Site
city: Iasi
country: Romania
facility: Novartis Investigative Site
city: Oradea
country: Romania
facility: Novartis Investigative Site
city: Targu Mures
country: Romania
facility: Novartis Investigative Site
city: Barnaul
country: Russian Federation
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: N.Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov-on-Don
country: Russian Federation
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Tver
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Belgrade
country: Serbia
facility: Novartis Investigative Site
city: Belgrade
country: Serbia
facility: Novartis Investigative Site
city: Knez Selo
country: Serbia
facility: Novartis Investigative Site
city: Kragujevac
country: Serbia
facility: Novartis Investigative Site
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Humenné
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Liptovsky Hradok
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Partizanske
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Námestovo
country: Slovakia
facility: Novartis Investigative Site
state: Slovensko
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Povazska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Spisská Nová Ves
country: Slovakia
facility: Novartis Investigative Site
city: Berea
country: South Africa
facility: Novartis Investigative Site
state: Durban
city: Sandton
country: South Africa
facility: Novartis Investigative Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Gatesville
country: South Africa
facility: Novartis Investigative Site
city: Port Elizabeth
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sanlucar de Barrameda
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Torrelavega
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Burgos
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Ponferrada
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Salt
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Merida
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Pozuelo de Alarcón
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Cartagena
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Boras
country: Sweden
facility: Novartis Investigative Site
city: Luleå
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Trollhattan
country: Sweden
facility: Novartis Investigative Site
city: Uddevalla
country: Sweden
facility: Novartis Investigative Site
city: Tainan 704
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan ROC
city: Chiayi County
country: Taiwan
facility: Novartis Investigative Site
city: Niaosong Township
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei County
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
city: Songkla
country: Thailand
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kinikli / Denizli
country: Turkey
facility: Novartis Investigative Site
city: Manisa
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Huntingdon
country: United Kingdom
facility: Novartis Investigative Site
state: Cambridgeshire
city: Stockton
country: United Kingdom
facility: Novartis Investigative Site
state: Cleveland
city: Midsomer Norton
country: United Kingdom
facility: Novartis Investigative Site
state: Radstock
city: Axbridge
country: United Kingdom
facility: Novartis Investigative Site
state: Somerset
city: Taunton
country: United Kingdom
facility: Novartis Investigative Site
state: Somerset
city: South Shields
country: United Kingdom
facility: Novartis Investigative Site
state: Tyne and Wear
city: Crawley
country: United Kingdom
facility: Novartis Investigative Site
state: West Sussex
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
city: Chester
country: United Kingdom
facility: Novartis Investigative Site
city: Darlington
country: United Kingdom
facility: Novartis Investigative Site
city: Lancashire
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
city: Tyne & Wear
country: United Kingdom
facility: Novartis Investigative Site
city: Wiltshire
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Mackay AJ, Kostikas K, Roche N, Frent SM, Olsson P, Pfister P, Gupta P, Patalano F, Banerji D, Wedzicha JA. Impact of baseline symptoms and health status on COPD exacerbations in the FLAME study. Respir Res. 2020 Apr 22;21(1):93. doi: 10.1186/s12931-020-01354-8.
citation: Wedzicha JA, Singh D, Tsiligianni I, Jenkins C, Fucile S, Fogel R, Shen S, Goyal P, Mezzi K, Kostikas K. Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. Respir Res. 2019 Jan 8;20(1):4. doi: 10.1186/s12931-019-0972-7.
citation: Frent SM, Chapman KR, Larbig M, Mackay A, Fogel R, Gutzwiller FS, Shen S, Patalano F, Banerji D, Kostikas K, Wedzicha JA. Capturing Exacerbations of Chronic Obstructive Pulmonary Disease with EXACT. A Subanalysis of FLAME. Am J Respir Crit Care Med. 2019 Jan 1;199(1):43-51. doi: 10.1164/rccm.201801-0038OC.
citation: Anzueto AR, Kostikas K, Mezzi K, Shen S, Larbig M, Patalano F, Fogel R, Banerji D, Wedzicha JA. Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study. Respir Res. 2018 Jun 20;19(1):121. doi: 10.1186/s12931-018-0830-z.
citation: Roche N, Chapman KR, Vogelmeier CF, Herth FJF, Thach C, Fogel R, Olsson P, Patalano F, Banerji D, Wedzicha JA. Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1189-1197. doi: 10.1164/rccm.201701-0193OC.
citation: Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.