Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
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
2 other identifiers
interventional
3,092
40 countries
391
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Dec 2015
Longer than P75 for phase_3 asthma
391 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedStudy Start
First participant enrolled
December 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedResults Posted
Study results publicly available
July 22, 2020
CompletedJuly 22, 2020
July 1, 2020
3.5 years
October 5, 2015
June 12, 2020
July 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The primary endpoint considered the following 2 comparison groups: * QVM149 150/50/80 μg o.d. compared with QMF149 150/160 μg o.d. both delivered via Concept1 * QVM149 150/50/160 μg o.d. compared with QMF149 150/320 μg o.d. both delivered via Concept1.
26 weeks
Secondary Outcomes (23)
Asthma Control Questionnaire (ACQ-7) at Week 26 and Week 52
26 weeks, 52 weeks
Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus Salmeterol/Fluticasone at Week 26
26 weeks
Trough FEV1 at Week 52
52 weeks
Pre-dose Forced Vital Capacity (FVC) at Week 4 and Week 12
4 weeks, 12 weeks
Trough Forced Expiratory Flow (FEF) Between 25% and 75% of FVC (FEF25-75) at 52 Weeks
Up to Week 52
- +18 more secondary outcomes
Study Arms (5)
QVM149 150/50/160 µg o.d.
EXPERIMENTALQVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 µg o.d.
EXPERIMENTALQVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 µg o.d.
ACTIVE COMPARATORQMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 µg o.d.
ACTIVE COMPARATORQMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol/fluticasone 50/500 μg b.i.d.
ACTIVE COMPARATORSalmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (403)
Novartis Investigative Site
Bahía Blanca, Buenos Aires, 8000, Argentina
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CABA, Buenos Aires, C1056ABJ, Argentina
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CABA, Buenos Aires, C1414AIF, Argentina
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Florida, Buenos Aires, B1602DQD, Argentina
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Lanús, Buenos Aires, B8000XAV, Argentina
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Mar del Plata, Buenos Aires, 7600, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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Nueve de Julio, Buenos Aires, B6500EZL, Argentina
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San Nicolás de los Arroyos, Buenos Aires, B2900JUB, Argentina
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Vicente López, Buenos Aires, B1602DOH, Argentina
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Villa María, Córdoba Province, X5900JKA, Argentina
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Concepción del Uruguay, Entre Ríos Province, 3260, Argentina
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Godoy Cruz, Mendoza Province, M5500EOB, Argentina
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Santa Fe, Rosario, S2000DBS, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2000DBS, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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Rosario, Santa Fe Province, S2000JKR, Argentina
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Rosario, Santa Fe Province, S2000QID, Argentina
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Rosario, Santa Fe Province, S2000, Argentina
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San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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Buenos Aires, B1646EBJ, Argentina
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Buenos Aires, B1842DID, Argentina
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Buenos Aires, C1120AAC, Argentina
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Buenos Aires, C1125ABE, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5003DCE, Argentina
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Mendoza, 5500, Argentina
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Mendoza, M5500CBA, Argentina
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Paraná, 3100, Argentina
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Santa Fe, S3000FIL, Argentina
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Santa Fe, S3000FWO, Argentina
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Bludenz, 6700, Austria
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Feldbach, 8330, Austria
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Feldkirch, 6800, Austria
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Grieskirchen, 4710, Austria
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Gosselies, BEL, 6041, Belgium
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Hasselt, BEL, 3500, Belgium
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Jette, Brussels Capital, 1090, Belgium
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Braine L Alleud Waterloo, 1420, Belgium
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Brussels, 1000, Belgium
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Brussels, 1070, Belgium
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Erpent, 5100, Belgium
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Éghezée, 5310, Belgium
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Lebbeke, 9280, Belgium
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Liège, 4000, Belgium
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Malmedy, 4960, Belgium
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Plovdiv, BGR, 4000, Bulgaria
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Rousse, 7002, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1463, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Sherwood Park, Alberta, T8H 0N2, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Toronto, Ontario, M5T 3A9, Canada
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Toronto, Ontario, M6H 3M2, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Windsor, Ontario, N8X 2G1, Canada
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Windsor, Ontario, N8X 5A6, Canada
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Montreal, Quebec, H3G 1L5, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Victoriaville, Quebec, G6P 6P6, Canada
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Québec, G1V 4W2, Canada
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Curicó, Maule Region, 3341643, Chile
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Santiago, Santiago Metropolitan, 7500692, Chile
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Valparaíso, TX, 2341131, Chile
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Santiago, 9100, Chile
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Santiago, Chile
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Haikou, Hainan, 570311, China
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Nanjing, Jiangsu, 210009, China
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Suzhou, Jiangsu, 215006, China
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Changchun, Jilin, 130021, China
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Shenyang, Liaoning, 110000, China
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Shenyang, Liaoning, 110003, China
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Shenyang, Liaoning, 110011, China
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Shanghai, Shanghai Municipality, 200032, China
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Xian, Shanxi, 710061, China
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Chengdu, Sichuan, 610041, China
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Chongqing, 400037, China
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Shanghai, 200433, China
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Tianjin, 300052, China
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Bogota DC, 110221, Colombia
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Bogotá, 110221, Colombia
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Floridablanca, Colombia
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Medellín, Colombia
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Zagreb, HRV, 10 000, Croatia
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Petrinja, 44250, Croatia
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Zadar, 23000, Croatia
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Zagreb, 10000, Croatia
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Copenhagen NV, 2400, Denmark
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Hvidovre, 2650, Denmark
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Tallinn, 10117, Estonia
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Tallinn, 10138, Estonia
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Tallinn, 13419, Estonia
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Tartu, 51014, Estonia
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Jyväskylä, 40100, Finland
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Montpellier, Herault, 34059, France
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Bochum, North Rhine-Westphalia, D-44787, Germany
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Koblenz, North Rhine-Westphalia, 56068, Germany
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Cottbus, Saxony, 03050, Germany
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Geesthacht, Schleswig-Holstein, 12502, Germany
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Annaberg-Buchholz, 09456, Germany
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Aschaffenburg, 63739, Germany
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Berlin, 10119, Germany
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Berlin, 10367, Germany
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Berlin, 10717, Germany
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Berlin, 12159, Germany
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Berlin, 12203, Germany
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Berlin, 13057, Germany
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Berlin, 13156, Germany
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Bonn, 53119, Germany
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Darmstadt, 64283, Germany
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Frankfurt, 60389, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60313, Germany
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Halle, 06108, Germany
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Hamburg, 22299, Germany
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Hamburg, 22335, Germany
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Hanover, 30173, Germany
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Karlsruhe, 76137, Germany
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Leipzig, 04103, Germany
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Leipzig, 04275, Germany
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Leipzig, 04357, Germany
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Lübeck, 23558, Germany
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Mainz, 55131, Germany
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Mittweida, 09648, Germany
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Neu-Isenburg, 63263, Germany
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Potsdam, 14467, Germany
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Rüdersdorf, 15562, Germany
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Witten, 58452, Germany
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Heraklion Crete, Greece, 711 10, Greece
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Athens, GR, 115 27, Greece
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Thessaloniki, GR, 564 03, Greece
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Thessaloniki, GR, 564 29, Greece
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Thessaloniki, GR, 570 10, Greece
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Athens, 106 76, Greece
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Athens, 175 62, Greece
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Budaörs, HUN, 2040, Hungary
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Budapest, HUN, 1204, Hungary
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Eger, HUN, 3300, Hungary
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Kapuvár, HUN, 9330, Hungary
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Püspökladány, HUN, 4150, Hungary
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Tata, HUN, 2890, Hungary
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Balassagyarmat, 2660, Hungary
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Budapest, 1106, Hungary
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Gödöllő, 2100, Hungary
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Komárom, 2900, Hungary
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Mátészalka, 4700, Hungary
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Nyíregyháza, H-4400, Hungary
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Szarvas, 5540, Hungary
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Szeged, 6722, Hungary
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Szeged, 6772, Hungary
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Szigetszentmiklós, H-2310, Hungary
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Szigetvár, 7900, Hungary
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Guntur, Andhra Pradesh, 522 001, India
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Hyderabad, Andhra Pradesh, 500 058, India
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Vijayawada, Andhra Pradesh, 520008, India
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Visakhapatnam, Andhra Pradesh, 530002, India
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Patna, Bihar, 800014, India
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Ahmedabad, Gujarat, 380 060, India
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Ahmedabad, Gujarat, 380016, India
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Gurgaon, Haryana, 122 002, India
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Bangalore, Karnataka, 560060, India
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Hubli, Karnataka, 580022, India
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Mangalore, Karnataka, 575001, India
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Mysore, Karnataka, 570001, India
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Cherthala, Kerala, 688524, India
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Kochi, Kerala, 683 594, India
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Kozhikode, Kerala, 673008, India
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Mumbai, Maharashtra, 401107, India
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Nagpur, Maharashtra, 440010, India
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Nagpur, Maharashtra, 440019, India
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Nashik, Maharashtra, 422007, India
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Pune, Maharashtra, 411007, India
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Pune, Maharashtra, 411014, India
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Delhi, National Capital Territory of Delhi, 110063, India
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New Delhi, National Capital Territory of Delhi, 110 060, India
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Mohali, Punjab, 160 062, India
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Bikaner, Rajasthan, 334003, India
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Jaipur, Rajasthan, 302013, India
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Jaipur, Rajasthan, 302020, India
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Jaipur, Rajasthan, 302023, India
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Coimbatore, Tamil Nadu, 641 045, India
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Vellore, Tamil Nadu, 632 004, India
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Hyderabad, Telangana, 500 038, India
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Hyderabad, Telangana, 500004, India
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Kanpur, Uttar Pradesh, 208 002, India
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Dehradun, Uttarakhand, 248001, India
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Kolkata, West Bengal, 700 107, India
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Wilton, Cork, Ireland
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Dublin, 24, Ireland
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Ashkelon, 78278, Israel
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Beersheba, 8457108, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 7610001, Israel
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Tel Giborim, Holon, 58100, Israel
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Bari, BA, 70124, Italy
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Catania, CT, 95125, Italy
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Catanzaro, CZ, 88100, Italy
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Florence, FI, 50134, Italy
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Messina, ME, 98125, Italy
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Negrar, VR, 37024, Italy
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Ancona, 60127, Italy
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Messina, 98125, Italy
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Pordenone, 33170, Italy
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Roma, 00168, Italy
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Kasuga, Fukuoka, 816-0813, Japan
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Obihiro, Hokkaido, 080-0013, Japan
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Tomakomai, Hokkaido, 053-8506, Japan
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Himeji, Hyōgo, 672-8064, Japan
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Naka-gun, Ibaraki, 319-1113, Japan
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Kawasaki, Kanagawa, 215-0021, Japan
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Yokohama, Kanagawa, 223-0059, Japan
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Yokohama, Kanagawa, 231-8682, Japan
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Yokohama, Kanagawa, 232-0064, Japan
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Yokohama, Kanagawa, 236 0051, Japan
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Yokkaichi, Mie-ken, 510-8561, Japan
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Sendai, Miyagi, 980-0871, Japan
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Kurashiki, Okayama-ken, 712-8064, Japan
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Okayama, Okayama-ken, 702-8055, Japan
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Kishiwada, Osaka, 596-8501, Japan
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Tokyo, Shibuya Ku, 150 0013, Japan
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Hamamatsu, Shizuoka, 431-3192, Japan
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Chuo Ku, Tokyo, 104-0031, Japan
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Itabashi-ku, Tokyo, 173-8610, Japan
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Kokubunji, Tokyo, 185-0014, Japan
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Ōta-ku, Tokyo, 145 0063, Japan
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Shinagawa-ku, Tokyo, 142-8666, Japan
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Toshima Ku, Tokyo, 170 0003, Japan
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Amman, JOR, 11152, Jordan
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Amman, JOR, 11183, Jordan
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Balvi, LVA, 4501, Latvia
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Bauska, LVA, LV-3901, Latvia
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Daugavpils, LVA, LV-5417, Latvia
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Jūrmala, LVA, LV-2015, Latvia
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Rēzekne, LVA, LV-4600, Latvia
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Riga, LVA, 1021, Latvia
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Riga, LV, 1011, Latvia
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Riga, LV, LV-1038, Latvia
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Daugavpils, LV-5401, Latvia
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Riga, LV 1002, Latvia
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El Chouf, LBN, 1503201002, Lebanon
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Beirut, 1107 2020, Lebanon
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Beirut, 166378, Lebanon
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El Achrafiyé, 166830, Lebanon
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Vilnius, LTU, LT-04129, Lithuania
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Kaunas, LT, LT-50128, Lithuania
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Vilnius, LT, 01117, Lithuania
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Kaunas, LT-44320, Lithuania
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Kaunas, LT-45130, Lithuania
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Kaunas, LT-49449, Lithuania
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Kaunas, LT-50154, Lithuania
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Klaipėda, LT-92231, Lithuania
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Klaipėda, LT-92288, Lithuania
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Šiauliai, LT-76231, Lithuania
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Vilnius, 06122, Lithuania
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Guadalajara, Jalisco, 44100, Mexico
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Guadalajara, Jalisco, 44130, Mexico
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Guadalajara, Jalisco, 44160, Mexico
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Guadalajara, Jalisco, 44670, Mexico
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Zapopan, Jalisco, 45200, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Culiacan, State of Mexico, 80020, Mexico
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Oaxaca City, 68000, Mexico
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Veracruz, 91700, Mexico
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Related Publications (5)
van Zyl-Smit RN, Kerstjens HAM, Maspero J, Tanase AM, Lawrence D, Mezzi K, D'Andrea P, Chapman KR. Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses. Pulm Ther. 2023 Sep;9(3):395-409. doi: 10.1007/s41030-023-00234-y. Epub 2023 Aug 1.
PMID: 37526856DERIVEDKostikas K, Maspero JF, Chapman KR, Mezzi K, Jaumont X, Lawrence D, van Zyl-Smit R. Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study. Respir Med. 2023 Oct;217:107334. doi: 10.1016/j.rmed.2023.107334. Epub 2023 Jun 29.
PMID: 37392789DERIVEDOba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PMID: 36472162DERIVEDChapman 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.
PMID: 34452934DERIVEDKerstjens 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.
PMID: 32653074DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 8, 2015
Study Start
December 8, 2015
Primary Completion
June 14, 2019
Study Completion
June 14, 2019
Last Updated
July 22, 2020
Results First Posted
July 22, 2020
Record last verified: 2020-07