Clinical trial NCT01985334: Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen
Official title: A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: Moderate COPD, glycopyrronium bromide, indacaterol maleate and glycopyrronium bromide FDC, NVA237, QVA149
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 4389
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

Detailed description: The treatment epoch will last 12 weeks. The total duration of the study for each patient is 12 weeks (from randomization) plus 30 days of safety follow-up.

The study has three phases: screening phase (=wash-out period, if required), treatment phase and safety follow-up phase.

Eligible patients will be randomized to either receive glycopyrronium or indacaterol maleate and glycopyrronium bromide fixed dose combination or to remain in their baseline therapy, in an allocation ratio of 3:1 for each cluster (Groups A, B, C, and D), based on their COPD symptoms and baseline treatment:

Group A: Patients treated with any SABA ( Short-acting β2-adrenergic agonist) and/or SAMA (Short-acting muscarinic antagonist) as monotherapy or in free or fixed dose combination (FDC) will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group B: Patients treated with any LABA (Long-acting β2-adrenergic agonist) or LAMA (Long-acting muscarinic antagonist) monotherapy and mMRC score =1 point will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group C: Patients treated with any LABA and ICS (Inhaled corticosteroid) in free or FDC will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Group D: Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Due to low recruitment in Groups A and B that would lead to a significant delay of trial completion, a protocol amendment was made in order to close the recruitment of Groups A and B at the time the randomization in Groups C and D would be completed. Recruitment of the Groups C and D continued as originally planned

Eligibility criteria: Inclusion Criteria:

* Male and female adults aged ≥ 40 years
* Patients with moderate COPD according to the GOLD criteria 2013
* Current or ex-smokers who have a smoking history of at least 10 pack years
* Patients with airflow limitation indicated by a postbronchodilator FEV1 ≥50% and \<80% of the predicted normal value and a post-bronchodilator FEV1/FVC \<0.7 at Visit 2. Post- bronchodilator refers to within 10-15 min of inhalation of 400 μg (4x100 μg) of salbutamol
* Patients who, at Visit 1, have been for at least 3 months on a stable dose of one of the following COPD baseline treatments: \*Any SABA monotherapy (such as, but not limited to, salbutamol) \*Any SAMA monotherapy (such as, but not limited to, ipratropium) \*Any SABA and SAMA in free or FDC (such as, but not limited to, salbutamol/ipratropium) \*Any LABA monotherapy (such as, but not limited to, formoterol, salmeterol, indacaterol) \*Any LAMA monotherapy (such as, but not limited to, tiotropium, aclidinium) except glycopyrronium bromide (NVA237) \*Any LABA and ICS in free (ICS such as, but not limited to, beclomethasone, fluticasone) or FDC (such as, but not limited to, salmeterol/fluticasone, formoterol/budesonide).
* Patients with an mMRC score ≥1 at Visit 1.

Exclusion Criteria:

* Patients with conditions contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or to drugs of similar chemical classes or any component thereof: Anti-cholinergic agents, Long- and short-acting 2-adrenergic agonists, Sympathomimetic amines, Lactose or any of the other excipients of the trial medication.
* Patients with narrow-angle glaucoma or urinary retention, severe renal impairment (history of estimated glomerular filtration rate below 30 ml/min/1.73 m2 within 12 months prior to visit 1), including those with end-stage renal disease requiring dialysis.
* Patients with active/ clinical history of asthma.If the Investigator finds clear and compelling evidence that a patient was misdiagnosed with asthma in the past, then the burden of proof is on the Investigator to properly document this previous misdiagnosis. This documentation must include the rationale for this change in diagnosis including reference to the differential diagnosis that supports this decision.
* Patients with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Patients who have a post-bronchodilator FEV1 decrease more than 10% compared to pre-bronchodilator FEV1 result at Visit 2 (see Appendix 5 for details).
* A documented history of \>1 COPD exacerbation requiring treatment with systemic corticosteroids or antibiotics and/or hospitalization in the previous 12 months.
* Patients who have NOT had a COPD exacerbation in the previous 12 months and develop a COPD exacerbation between screening (Visit 1) and (Visit 2) 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 suffering an exacerbation between Visit 1 and Visit 2 can only be re-screened in case it is the first one in the previous 12 months. In case this COPD exacerbation has led to an alteration of the patient COPD treatment, before this patient can be re-screened 3 months of stable COPD treatment will be required as described in Inclusion Criterion 6).
* Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to): \*Unstable ischemic heart disease, left ventricular failure (NYHA Class III \& IV), history of myocardial infarction,arrhythmia (excluding chronic stable atrial fibrillation). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study.\*Uncontrolled hypo-or hyperthyroidism, hypokalaemia or hyperadrenergic state. \*Any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
* History of resting QTc (Fridericia preferred, but Bazett acceptable) \>450 msec (male) or \>460 msec (female) within five years before Visit 1.
* Patients who are treated with glycopyrronium bromide (NVA237) at visit 1 are not allowed to be included into the trialPatients on non-selective beta-blockers. Those patients may enter the study after non-selective beta-blocker withdrawal during a 7-day wash-out period.
* Patients receiving any other prohibited COPD-related medications specified in Table 5-2 Prohibited COPD related medications must undergo the required wash-out period prior to Visit 2.
* Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.
* Patients with a body mass index (BMI) of more than 40 kg/m2.
* Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer.
* 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 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.

Primary outcomes:
measure: Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)
timeFrame: Week 12 (Visit 4)
measure: Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
timeFrame: Week 12 (Visit 4)
measure: Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC
timeFrame: Week 12 (Visit 4)
measure: Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
timeFrame: Week 12 (Visit 4)
measure: Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)
timeFrame: Day 1 (baseline) and week 12
measure: Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
timeFrame: Day 1 (baseline) and week 12
measure: Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC
timeFrame: Day 1 (baseline) and week 12
measure: Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
timeFrame: Day 1 (baseline) and week 12
Secondary outcomes:
measure: Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
timeFrame: 12 Weeks
measure: Change From Baseline on on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or Long-acting Bronchodilators (LABA or LAMA Monotherapy)
timeFrame: Day 1 (baseline) and week 12
measure: Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.
timeFrame: 12 Weeks
measure: Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC
timeFrame: Day 1 (baseline) and week 12
measure: Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
timeFrame: Day 1 (baseline) and Week 12
measure: Change From Baseline on Total Score of Clinical COPD Questionnaire (CCQ) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
timeFrame: Day 1 (baseline) and Week 12
measure: Mean Number of Puffs of Rescue Medication Use for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
timeFrame: 12 weeks
measure: Mean Change From Baseline Reported Symptoms of COPD for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
timeFrame: Baseline, 12 weeks
Other outcomes:
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Berlin
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city: Essen
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city: Essen
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city: Essen
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
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country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Köthen
country: Germany
facility: Novartis Investigative Site
city: Landau-Pfalz
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: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leonberg
country: Germany
facility: Novartis Investigative Site
city: Leverkusen
country: Germany
facility: Novartis Investigative Site
city: Limburgerhof
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Ludwigsburg
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Luedenscheid
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Mayen
country: Germany
facility: Novartis Investigative Site
city: Meine
country: Germany
facility: Novartis Investigative Site
city: Meissen
country: Germany
facility: Novartis Investigative Site
city: Menden
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Mittweida
country: Germany
facility: Novartis Investigative Site
city: Mülheim
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Münnerstadt
country: Germany
facility: Novartis Investigative Site
city: Neu Isenburg
country: Germany
facility: Novartis Investigative Site
city: Neu-Ulm
country: Germany
facility: Novartis Investigative Site
city: Neunkirchen
country: Germany
facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Neuwied
country: Germany
facility: Novartis Investigative Site
city: Northeim
country: Germany
facility: Novartis Investigative Site
city: Nürnberg
country: Germany
facility: Novartis Investigative Site
city: Nürnberg
country: Germany
facility: Novartis Investigative Site
city: Obermichelbach
country: Germany
facility: Novartis Investigative Site
city: Oschatz
country: Germany
facility: Novartis Investigative Site
city: Oschersleben
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Papenburg
country: Germany
facility: Novartis Investigative Site
city: Passau
country: Germany
facility: Novartis Investigative Site
city: Plauen
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: Radebeul
country: Germany
facility: Novartis Investigative Site
city: Ratingen
country: Germany
facility: Novartis Investigative Site
city: Raubach
country: Germany
facility: Novartis Investigative Site
city: Reinfeld
country: Germany
facility: Novartis Investigative Site
city: Rheine
country: Germany
facility: Novartis Investigative Site
city: Rodenbach
country: Germany
facility: Novartis Investigative Site
city: Roth
country: Germany
facility: Novartis Investigative Site
city: Rudersdorf
country: Germany
facility: Novartis Investigative Site
city: Rüsselsheim,
country: Germany
facility: Novartis Investigative Site
city: Rüsselsheim
country: Germany
facility: Novartis Investigative Site
city: Saalfeld
country: Germany
facility: Novartis Investigative Site
city: Saarbruecken
country: Germany
facility: Novartis Investigative Site
city: Schleswig
country: Germany
facility: Novartis Investigative Site
city: Schwabach
country: Germany
facility: Novartis Investigative Site
city: Schwedt
country: Germany
facility: Novartis Investigative Site
city: Schwerin
country: Germany
facility: Novartis Investigative Site
city: Schwetzingen
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Sinsheim
country: Germany
facility: Novartis Investigative Site
city: Solingen
country: Germany
facility: Novartis Investigative Site
city: Solingen
country: Germany
facility: Novartis Investigative Site
city: Solingen
country: Germany
facility: Novartis Investigative Site
city: Sonneberg
country: Germany
facility: Novartis Investigative Site
city: Strausberg
country: Germany
facility: Novartis Investigative Site
city: Teuchern
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wardenburg
country: Germany
facility: Novartis Investigative Site
city: Weilheim
country: Germany
facility: Novartis Investigative Site
city: Welzheim
country: Germany
facility: Novartis Investigative Site
city: Westerkappeln
country: Germany
facility: Novartis Investigative Site
city: Wiesloch
country: Germany
facility: Novartis Investigative Site
city: Wissen
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Woellstein
country: Germany
facility: Novartis Investigative Site
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
city: Zerbst
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
state: GR
city: Serres
country: Greece
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Szazhalombatta
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Cegled
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Hatvan
country: Hungary
facility: Novartis Investigative Site
city: Komarom
country: Hungary
facility: Novartis Investigative Site
city: Mako
country: Hungary
facility: Novartis Investigative Site
city: Mateszalka
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Tatabanya
country: Hungary
facility: Novartis Investigative Site
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
city: County Limerick
country: Ireland
facility: Novartis Investigative Site
city: Dublin 7
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Avellino
country: Italy
facility: Novartis Investigative Site
state: AV
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Terlizzi
country: Italy
facility: Novartis Investigative Site
state: BA
city: Triggiano
country: Italy
facility: Novartis Investigative Site
state: BA
city: Romano di Lombardia
country: Italy
facility: Novartis Investigative Site
state: BG
city: Feltre
country: Italy
facility: Novartis Investigative Site
state: BL
city: Telese Terme
country: Italy
facility: Novartis Investigative Site
state: BN
city: San Pietro Vernotico
country: Italy
facility: Novartis Investigative Site
state: BR
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Campobasso
country: Italy
facility: Novartis Investigative Site
state: CB
city: Marcianise
country: Italy
facility: Novartis Investigative Site
state: CE
city: Caltanissetta
country: Italy
facility: Novartis Investigative Site
state: CL
city: Saluzzo
country: Italy
facility: Novartis Investigative Site
state: CN
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Forlì
country: Italy
facility: Novartis Investigative Site
state: FC
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: FG
city: San Severo
country: Italy
facility: Novartis Investigative Site
state: FG
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Livorno
country: Italy
facility: Novartis Investigative Site
state: LI
city: Lodi
country: Italy
facility: Novartis Investigative Site
state: LO
city: Lido di Camaiore
country: Italy
facility: Novartis Investigative Site
state: LU
city: Monza
country: Italy
facility: Novartis Investigative Site
state: MB
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Nuoro
country: Italy
facility: Novartis Investigative Site
state: NU
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Piacenza
country: Italy
facility: Novartis Investigative Site
state: PC
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: Voghera
country: Italy
facility: Novartis Investigative Site
state: PV
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Riccione
country: Italy
facility: Novartis Investigative Site
state: RN
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Sondalo
country: Italy
facility: Novartis Investigative Site
state: SO
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: SS
city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Terni
country: Italy
facility: Novartis Investigative Site
state: TR
city: Montebelluna
country: Italy
facility: Novartis Investigative Site
state: TV
city: Vittorio Veneto
country: Italy
facility: Novartis Investigative Site
state: TV
city: Busto Arsizio
country: Italy
facility: Novartis Investigative Site
state: VA
city: Arzignano
country: Italy
facility: Novartis Investigative Site
state: VI
city: Vicenza
country: Italy
facility: Novartis Investigative Site
state: VI
city: Bussolengo
country: Italy
facility: Novartis Investigative Site
state: VR
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
city: Balvi
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Jurmala
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
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: Riga
country: Latvia
facility: Novartis Investigative Site
city: Vilnius
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: Utena
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Førde
country: Norway
facility: Novartis Investigative Site
city: Kløfta
country: Norway
facility: Novartis Investigative Site
city: Lierskogen
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Skedsmokorset
country: Norway
facility: Novartis Investigative Site
city: Skien
country: Norway
facility: Novartis Investigative Site
city: Stavanger
country: Norway
facility: Novartis Investigative Site
city: Tananger
country: Norway
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Nowy Dwor Mazowiecki
country: Poland
facility: Novartis Investigative Site
city: Ostrow Wielkopolski
country: Poland
facility: Novartis Investigative Site
city: Pila
country: Poland
facility: Novartis Investigative Site
city: Sopot
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Aveiro
country: Portugal
facility: Novartis Investigative Site
city: Barcelos
country: Portugal
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Guimarães
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: Vila Franca de Xira
country: Portugal
facility: Novartis Investigative Site
city: Vila Nova de Gaia
country: Portugal
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 3
city: Iasi
country: Romania
facility: Novartis Investigative Site
state: Jud. Iasi
city: Bacau
country: Romania
facility: Novartis Investigative Site
city: Bragadiru
country: Romania
facility: Novartis Investigative Site
city: Constanta
country: Romania
facility: Novartis Investigative Site
city: Ramnicu Valcea
country: Romania
facility: Novartis Investigative Site
city: Suceava
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: N.Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tomsk
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: Bardejov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Liptovsky Hradok
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Námestovo
country: Slovakia
facility: Novartis Investigative Site
state: Slovensko
city: Kralovsky Chlmec
country: Slovakia
facility: Novartis Investigative Site
city: Levice
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Sala
country: Slovakia
facility: Novartis Investigative Site
city: Sturovo
country: Slovakia
facility: Novartis Investigative Site
city: Trnava
country: Slovakia
facility: Novartis Investigative Site
city: Vrable
country: Slovakia
facility: Novartis Investigative Site
city: Golnik
country: Slovenia
facility: Novartis Investigative Site
city: Kranj
country: Slovenia
facility: Novartis Investigative Site
city: Maribor
country: Slovenia
facility: Novartis Investigative Site
city: Murska Sobota
country: Slovenia
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Marbella
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Marbella
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Málaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Centelles
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Mataro
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Sant Joan Despi
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Vic
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Ponferrada
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Salamanca
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Canet de Mar
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Sant Boi de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Vic
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
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country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Puerto De Sagunto
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
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country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
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country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
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country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
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country: Spain
facility: Novartis Investigative Site
state: Extremadura
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country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Motril
country: Spain
facility: Novartis Investigative Site
state: Granada
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country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
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country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
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country: Spain
facility: Novartis Investigative Site
state: Madrid, Communidad De
city: Mostoles
country: Spain
facility: Novartis Investigative Site
state: Madrid, Communidad De
city: Valdemoro
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Linkoping
country: Sweden
facility: Novartis Investigative Site
state: Ostergotlands Lan
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Gustavsberg
country: Sweden
facility: Novartis Investigative Site
city: Helsingborg
country: Sweden
facility: Novartis Investigative Site
city: Hollviken
country: Sweden
facility: Novartis Investigative Site
city: Kungshamn
country: Sweden
facility: Novartis Investigative Site
city: Limhamn
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Råå
country: Sweden
facility: Novartis Investigative Site
city: Umea
country: Sweden
facility: Novartis Investigative Site
city: Vastra Frolunda
country: Sweden
facility: Novartis Investigative Site
city: Aylesbury
country: United Kingdom
facility: Novartis Investigative Site
state: Bucks
city: Fowey
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Liskeard
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Penzance
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Redruth
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: St Austell
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Torpoint
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Bath
country: United Kingdom
facility: Novartis Investigative Site
state: England
city: Havant
country: United Kingdom
facility: Novartis Investigative Site
state: Hampshire
city: Burbage
country: United Kingdom
facility: Novartis Investigative Site
state: Leicester
city: Daventry
country: United Kingdom
facility: Novartis Investigative Site
state: Northamptonshire
city: Sneinton
country: United Kingdom
facility: Novartis Investigative Site
state: Nottingham
city: Axbridge
country: United Kingdom
facility: Novartis Investigative Site
state: Somerset
city: Frome
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: Barry
country: United Kingdom
facility: Novartis Investigative Site
state: Vale Of Glamorgan
city: Leamington Spa
country: United Kingdom
facility: Novartis Investigative Site
state: Warwickshire
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: Trowbridge
country: United Kingdom
facility: Novartis Investigative Site
state: Wiltshire
city: Strensall
country: United Kingdom
facility: Novartis Investigative Site
state: Yorkshire
city: Bexhill-on-Sea
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: Chadderton
country: United Kingdom
facility: Novartis Investigative Site
city: Cheshire
country: United Kingdom
facility: Novartis Investigative Site
city: Chesterfield
country: United Kingdom
facility: Novartis Investigative Site
city: Chippenham
country: United Kingdom
facility: Novartis Investigative Site
city: Coventry
country: United Kingdom
facility: Novartis Investigative Site
city: Hamilton
country: United Kingdom
facility: Novartis Investigative Site
city: Lancashire
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Motherwell
country: United Kingdom
facility: Novartis Investigative Site
city: Oldham
country: United Kingdom
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
city: Shrewsbury
country: United Kingdom
facility: Novartis Investigative Site
city: South Yorkshire
country: United Kingdom
facility: Novartis Investigative Site
city: Stockton on Tees
country: United Kingdom
facility: Novartis Investigative Site
city: Vale Of Glanmorgan
country: United Kingdom
facility: Novartis Investigative Site
city: Watford
country: United Kingdom
facility: Novartis Investigative Site
city: Wiltshire
country: United Kingdom
facility: Novartis Investigative Site
city: Wishaw
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Greulich T, Kostikas K, Gaga M, Aalamian-Mattheis M, Lossi NS, Patalano F, Nunez X, Pagano VA, Fogel R, Vogelmeier CF, Clemens A. Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1229-1237. doi: 10.2147/COPD.S159732. eCollection 2018.
citation: Vogelmeier CF, Gaga M, Aalamian-Mattheis M, Greulich T, Marin JM, Castellani W, Ninane V, Lane S, Nunez X, Patalano F, Clemens A, Kostikas K; CRYSTAL study investigators. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017 Jul 18;18(1):140. doi: 10.1186/s12931-017-0622-x.