Clinical trial NCT02571777: Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
Official title: A Multicenter, Randomized, 52-week, Double-blind, Parallelgroup, Active Controlled Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
QVM149
QMF149
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 3092
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

Detailed description: This study used a 52-week treatment, randomized, double-blind, double-dummy, parallel-group design. A total of 3092 asthma patients were randomized into the 5 treatment groups with a randomization ratio of 1:1:1:1:1 (approximately 617 patients per treatment group): QVM149 150/50/80 μg once daily (o.d.), QVM149 150/50/160 μg o.d., QMF149 150/160 μg o.d. and QMF149 150/320 μg o.d., all delivered via the Concept1 device, and salmeterol/fluticasone 50/500 μg twice daily (b.i.d.) delivered via Accuhaler. The 52 week treatment period was followed by a 30-day Follow-up.

The primary objective of this study was to demonstrate superiority of either QVM149 150/50/80 μg o.d. to QMF149 150/160 μg o.d. or QVM149 150/50/160 μg o.d. to QMF149 150/320 μg o.d in terms of trough Forced Expiratory Volume in One Second (Trough FEV1) (FEV1) at Week 26, all delivered via Concept1.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of asthma, (GINA 2015) for a period of at least 1 year prior to Visit 1 (Screening).
* Patients who have used medium or high dose of ICS/LABA combinations for asthma for at least 3 months and at stable medium or high doses of ICS/LABA for at least 1 month prior to Visit 1.
* Patients must be symptomatic at screening despite treatment with mid or high stable doses of ICS/LABA. Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (before randomization).
* Patients with documented history of at least one asthma exacerbation which required medical care from a physician, ER visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1, and required systemic corticosteroid treatment.
* Pre-bronchodilator FEV1 of \< 80 % of the predicted normal value for the patient according to ATS/ERS guidelines after withholding bronchodilators at both visits 101 and 102.
* Withholding period of bronchodilators prior to spirometry: SABA for ≥ 6 hrs, Twice daily LABA (or FDC of ICS/LABA) for ≥ 12 hrs, Once daily LABA (or FDC of ICS/LABA) for ≥ 24 hrs, SAMA for ≥ 8 hrs, Short acting xanthines for 12 hrs, Long acting xanthines for 24 hrs, .
* Washout period of each drug should be kept as close as possible as above and should not be longer. If longer washout period is needed due to scheduling issues, please contact Novartis Medical monitor.
* A one-time repeat of percentage predicated FEV1 (Pre-bronchodilator) at Visit 101 and/or Visit 102 is allowed in an ad-hoc visit. Repeat of Visit 101 spirometry should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment before randomization. Run-in medication should be dispensed once spirometry assessment met inclusion criteria (ATS/ERS quality criteria, FEV1 % predicted normal value, and reversibility) as per equipment
* A one-time rescreen is allowed in case the patient fails to meet the criteria at the repeat, provided the patient returned to the required treatment as per inclusion criteria 4
* Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101.All patients must perform a reversibility test at Visit 101. If reversibility is not demonstrated at Visit 101 then one of the following criteria need to be met.
* Reversibility should be repeated once.
* Patients may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1.
* Alternatively, patients may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1. If reversibility is not demonstrated at Visit 101 (or after repeated assessment in an ad-hoc visit) and historical evidence of reversibility/bronchoprovocation is not available (or was not performed according to the ATS/ERS guidelines patients must be screen failed
* Spacer devices are permitted during reversibility testing only. The Investigator or delegate may decide whether or not to use a spacer for the reversibility testing

Exclusion Criteria:

* Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening). If patients experience an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation.
* Patients who have ever required intubation for a severe asthma attack/exacerbation.
* Patients who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study.
* Patients treated with a LAMA for asthma within 3 months prior Visit 1 (Screening).
* Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention. BPH patients who are stable on treatment can be considered).
* Patients who have had a respiratory tract infection or asthma worsening as determined by investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
* Patients with evidence upon visual inspection (laboratory culture is not required) of clinically significant (in the opinion of investigator) oropharyngeal candidiasis at Visit 102 or earlier, with or without treatment. Patients may be re-screened once their candidiasis has been treated and has resolved.
* Patients with any chronic conditions affecting the upper respiratory tract (e.g. chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
* Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
* Patients with Type I diabetes or uncontrolled Type II diabetes.
* Patients who, either in the judgment of the investigator or the responsible Novartis personnel, have a clinically significant condition such as (but not limited to) unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease, psychiatric disease, neurodegenerative diseases, or other neurological disease, uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia, hyperadrenergic state, or ophthalmologic disorder or patients with a medical condition that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
* 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 blockers, 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 the run-in visit (Visit 101) with a resting ventricular rate \< 100/min. At Visit 101 the atrial fibrillation must be confirmed by central reading.
* Patients with a history of myocardial infarction (this should be confirmed clinically by the investigator) within the previous 12 months.
* Concomitant use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study
* Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (\> 450 msec for males and \> 460 msec for females) and confirmed by a central assessor (these patients should not be rescreened).
* Patients with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
* Patients who have not achieved an acceptable spirometry result at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability. A one-time repeat spirometry is allowed in an ad-hoc visit scheduled as close as possible from the first attempt (but not on the same day) if the spirometry did not qualify due to ATS/ERS criteria at Visit 101 and/or Visit 102. If the patient fails the repeat assessment, the patient may be rescreened once, provided the patient returns to the required treatment as per inclusion criteria 4.
* Patients unable to use the Concept1 dry powder inhaler, Accuhaler or a metered dose inhaler. Spacer devices are not permitted.
* History of alcohol or other substance abuse.
* Patients with a known history of non-compliance to medication or who were unable or unwilling to complete a patient diary or who are unable or unwilling to use Electronic Peak Flow with e-diary device.
* Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26
timeFrame: 26 weeks
Secondary outcomes:
measure: Asthma Control Questionnaire (ACQ-7) at Week 26 and Week 52
timeFrame: 26 weeks, 52 weeks
measure: Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus Salmeterol/Fluticasone at Week 26
timeFrame: 26 weeks
measure: Trough FEV1 at Week 52
timeFrame: 52 weeks
measure: Pre-dose Forced Vital Capacity (FVC) at Week 4 and Week 12
timeFrame: 4 weeks, 12 weeks
measure: Trough Forced Expiratory Flow (FEF) Between 25% and 75% of FVC (FEF25-75) at 52 Weeks
timeFrame: Up to Week 52
measure: Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
timeFrame: Baseline, 26 weeks, 52 weeks
measure: Change From Baseline in Percentage of Asthma Symptom-free Days Over 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Percentage of Days With no Daytime Symptoms Over 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Percentage of Nights With no Night-time Awakenings Over 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Percentage of Mornings With no Symptoms on Rising Over 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Percentage of Days Without Rescue Medication Use Over 26 and 52 Weeks
timeFrame: Baseline, 26 weeks, 52 weeks
measure: Percentage of Patients Achieving the Minimal Clinically Important Difference (MCID) ACQ ≥ 0.5 at Week 26 and Week 52
timeFrame: 26 weeks, 52 weeks
measure: Time to First Hospitalization for Asthma Exacerbation
timeFrame: 52 weeks on average, up to 416 days
measure: Time to First Asthma Exacerbation by Exacerbation Category
timeFrame: 52 weeks on average, up to 416 days
measure: Annual Rate of Asthma Exacerbations by Exacerbation Category
timeFrame: 52 weeks
measure: Duration in Days of Asthma Exacerbations by Exacerbation Category
timeFrame: Up to Week 52
measure: Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
timeFrame: Up to Week 52
measure: Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbation
timeFrame: 52 weeks on average, up to 416 days
measure: Total Amount of Oral Corticosteroid Used (in Prednisone-equivalent mg Doses) to Treat Asthma Exacerbations
timeFrame: Up to Week 52
measure: Change From Baseline in Percentage of Rescue Medication Free Days Over 26 and 52 Weeks
timeFrame: Baseline, 26 weeks, 52 weeks
measure: Asthma Quality of Life Questionnaire (AQLQ) at Week 52
timeFrame: 52 weeks
measure: Pre-dose FEV1 at Weeks 4 and 12
timeFrame: 4 weeks, 12 weeks
measure: Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes
timeFrame: Up to Week 52
Other outcomes:
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country: India
facility: Novartis Investigative Site
state: West Bengal
city: Wilton
country: Ireland
facility: Novartis Investigative Site
state: Cork
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Ashkelon
country: Israel
facility: Novartis Investigative Site
city: Beer-Sheva
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Kfar Saba
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Tel Giborim, Holon
country: Israel
facility: Novartis Investigative Site
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Catanzaro
country: Italy
facility: Novartis Investigative Site
state: CZ
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Negrar
country: Italy
facility: Novartis Investigative Site
state: VR
city: Ancona
country: Italy
facility: Novartis Investigative Site
city: Messina
country: Italy
facility: Novartis Investigative Site
city: Pordenone
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Kasuga-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Obihiro-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Tomakomai-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Himeji-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Naka-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokkaichi-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Sendai-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Kurashiki-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Kishiwada-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Tokyo
country: Japan
facility: Novartis Investigative Site
state: Shibuya Ku
city: Hamamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kokubunji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Amman
country: Jordan
facility: Novartis Investigative Site
state: JOR
city: Amman
country: Jordan
facility: Novartis Investigative Site
state: JOR
city: Balvi
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Bauska
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Jurmala
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Rezekne
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Riga
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: El Chouf
country: Lebanon
facility: Novartis Investigative Site
state: LBN
city: Ashrafieh
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
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: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Kaunas
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: Siauliai
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Culiacan
country: Mexico
facility: Novartis Investigative Site
state: MEX
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo Leon
city: Oaxaca
country: Mexico
facility: Novartis Investigative Site
city: Veracruz
country: Mexico
facility: Novartis Investigative Site
city: Breda
country: Netherlands
facility: Novartis Investigative Site
state: CK
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Harderwijk
country: Netherlands
facility: Novartis Investigative Site
city: Heerlen
country: Netherlands
facility: Novartis Investigative Site
city: Helmond
country: Netherlands
facility: Novartis Investigative Site
city: Hengelo
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Zutphen
country: Netherlands
facility: Novartis Investigative Site
city: Cercado De Lima
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Borja
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Miguel
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Lima
country: Peru
facility: Novartis Investigative Site
city: Lipa City
country: Philippines
facility: Novartis Investigative Site
state: Batangas
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Bulacan
country: Philippines
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Ksawerow
country: Poland
facility: Novartis Investigative Site
state: POL
city: Wejherowo
country: Poland
facility: Novartis Investigative Site
state: POL
city: Aleksandrow Odzki
country: Poland
facility: Novartis Investigative Site
city: Bielsko-Biala
country: Poland
facility: Novartis Investigative Site
city: Elblag
country: Poland
facility: Novartis Investigative Site
city: Inowroclaw
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Ostrow Wielkopolski
country: Poland
facility: Novartis Investigative Site
city: Sopot
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Zawadzkie
country: Poland
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: ROM
city: Deva
country: Romania
facility: Novartis Investigative Site
state: ROM
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Arad
country: Romania
facility: Novartis Investigative Site
city: Bacau
country: Romania
facility: Novartis Investigative Site
city: Brasov
country: Romania
facility: Novartis Investigative Site
city: Brasov
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: Cluj Napoca
country: Romania
facility: Novartis Investigative Site
city: Cluj-Napoca
country: Romania
facility: Novartis Investigative Site
city: Constanta
country: Romania
facility: Novartis Investigative Site
city: Deva
country: Romania
facility: Novartis Investigative Site
city: Pitesti
country: Romania
facility: Novartis Investigative Site
city: Barnaul
country: Russian Federation
facility: Novartis Investigative Site
city: Barnaul
country: Russian Federation
facility: Novartis Investigative Site
city: Barnaul
country: Russian Federation
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ivanovo
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: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Omsk
country: Russian Federation
facility: Novartis Investigative Site
city: Perm
country: Russian Federation
facility: Novartis Investigative Site
city: Perm
country: Russian Federation
facility: Novartis Investigative Site
city: Pskov
country: Russian Federation
facility: Novartis Investigative Site
city: Pyatigorsk
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
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: Sestroretsk
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
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: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tomsk
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: Ulyanovsk
country: Russian Federation
facility: Novartis Investigative Site
city: Vladikavkaz
country: Russian Federation
facility: Novartis Investigative Site
city: Volgograd
country: Russian Federation
facility: Novartis Investigative Site
city: Vsevolozhsk
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kezmarok
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Liptovsky Mikulas
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Spisska Nova Ves
country: Slovakia
facility: Novartis Investigative Site
city: Trencin
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Zvolen
country: Slovakia
facility: Novartis Investigative Site
city: Berea
country: South Africa
facility: Novartis Investigative Site
state: Durban
city: Durban
country: South Africa
facility: Novartis Investigative Site
state: Kwazulu Natal
city: Kempton Park
country: South Africa
facility: Novartis Investigative Site
state: ZAF
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Marbella
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Esparraguera
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Laredo
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Vila-real
country: Spain
facility: Novartis Investigative Site
state: Castellon
city: Girona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Caceres
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: La Laguna
country: Spain
facility: Novartis Investigative Site
state: Santa Cruz De Tenerife
city: Leon
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Lidingo
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Gossau
country: Switzerland
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
state: Nonthaburi
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: East Yorkshire
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Wiltshire
country: United Kingdom
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
state: VNM
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
Study officials:
References:
citation: Chapman K, van Zyl-Smit R, Maspero J, Kerstjens HAM, Gon Y, Hosoe M, Tanase AM, Pethe A, Shu X, D'Andrea P. One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. BMJ Open Respir Res. 2021 Aug;8(1):e000819. doi: 10.1136/bmjresp-2020-000819.
citation: Kerstjens HAM, Maspero J, Chapman KR, van Zyl-Smit RN, Hosoe M, Tanase AM, Lavecchia C, Pethe A, Shu X, D'Andrea P; IRIDIUM trial investigators. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):1000-1012. doi: 10.1016/S2213-2600(20)30190-9. Epub 2020 Jul 9.