A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma
NCT ID: NCT02554786
Last Updated: 2020-03-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2216 participants
INTERVENTIONAL
2015-12-29
2019-06-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
NCT02571777
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
NCT00941798
Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
NCT01609478
Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.
NCT03063086
Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma
NCT01555151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QMF149 150/160 µg
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered once daily (o.d) via Concept1 inhaler in the evening.
Indacaterol acetate/Mometasone furoate
QMF149 150/320 µg
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening.
Indacaterol acetate/Mometasone furoate
MF 400 µg
Mometasone furoate (MF) 400 μg was delivered o.d via Twisthaler® in the evening
Mometasone furoate
Salmeterol /fluticasone 50/500 μg
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Salmeterol xinafoate/fluticasone propionate
MF 800 μg
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
Mometasone furoate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Indacaterol acetate/Mometasone furoate
Mometasone furoate
Salmeterol xinafoate/fluticasone propionate
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants who have used medium or high dose inhaled corticosteroids (ICS) or low dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1
* Participants must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS
* Pre-bronchodilator ≥ 50% Forced expiratory volume in 1 second (FEV1) of \< 85 % of the predicted normal value for the participants after withholding bronchodilators at both Visit 101 and 102, according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria.
* Withholding period of bronchodilators prior to spirometry: short acting beta-2 agonist (SABA) for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, short acting anticholinergics (SAMA) for ≥ 8 hours, xanthines \>=07 days
* A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit 102.
Spacer devices are permitted for reversibility testing only.
-Participants 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 participants must perform a reversibility test at Visit 101
If reversibility is not demonstrated at Visit 101:
* Reversibility should be repeated once-
* Participants 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, participants may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1.
Exclusion Criteria
* Participants who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)
* Participants who have ever required intubation for a severe asthma attack/exacerbation.
* Participants 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).
* Participants who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Participants may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
* Participants with a history of chronic lung diseases other than asthma, including (but not limited to) Chronic Obstructive Pulmonary Disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
* Participants with severe narcolepsy and/or insomnia.
* Participants who have a clinically significant electrocardiogram (ECG) abnormality at Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation
* Participants 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
* Participants who have not achieved an acceptable spirometry results at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability (rescreening allowed only once).
Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the participant fails the repeat assessment, the participant may be rescreened once
* Participants on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or participants on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 30 days after stopping of study treatment.
* Long acting muscarinic antagonist (LAMA) use within 3 months prior to Visit 101
12 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Orange, California, United States
Novartis Investigative Site
Riverside, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Jose, California, United States
Novartis Investigative Site
Stockton, California, United States
Novartis Investigative Site
Westminster, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Tallahassee, Florida, United States
Novartis Investigative Site
Winter Park, Florida, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Waldorf, Maryland, United States
Novartis Investigative Site
North Dartmouth, Massachusetts, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Bellevue, Nebraska, United States
Novartis Investigative Site
Las Vegas, Nevada, United States
Novartis Investigative Site
Skillman, New Jersey, United States
Novartis Investigative Site
Cortland, New York, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Tulsa, Oklahoma, United States
Novartis Investigative Site
Medford, Oregon, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
North Charleston, South Carolina, United States
Novartis Investigative Site
Boerne, Texas, United States
Novartis Investigative Site
El Paso, Texas, United States
Novartis Investigative Site
Greenfield, Wisconsin, United States
Novartis Investigative Site
Plovdiv, BGR, Bulgaria
Novartis Investigative Site
Varna, BGR, Bulgaria
Novartis Investigative Site
Vidin, BGR, Bulgaria
Novartis Investigative Site
Pleven, , Bulgaria
Novartis Investigative Site
Plovdiv, , Bulgaria
Novartis Investigative Site
Rousse, , Bulgaria
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Stara Zagora, , Bulgaria
Novartis Investigative Site
Troyan Municipality, , Bulgaria
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Fuzhou, Fujian, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Haikou, Hainan, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Suzhou, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Shanghai, Shanghai Municipality, China
Novartis Investigative Site
Xian, Shanxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Chengdu, , China
Novartis Investigative Site
Chongqing, , China
Novartis Investigative Site
Guangzhou, , China
Novartis Investigative Site
Guangzhou, , China
Novartis Investigative Site
Guangzhou, , China
Novartis Investigative Site
Nanchang, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Tianjin, , China
Novartis Investigative Site
Varaždin, HRV, Croatia
Novartis Investigative Site
Zagreb, HRV, Croatia
Novartis Investigative Site
Petrinja, , Croatia
Novartis Investigative Site
Rijeka, , Croatia
Novartis Investigative Site
Zadar, , Croatia
Novartis Investigative Site
Zagreb, , Croatia
Novartis Investigative Site
Beroun, Czech Republic, Czechia
Novartis Investigative Site
Boskovice, Czech Republic, Czechia
Novartis Investigative Site
Jablonec nad Nisou, Czech Republic, Czechia
Novartis Investigative Site
Jindřichův Hradec, Czech Republic, Czechia
Novartis Investigative Site
Kuřim, Czech Republic, Czechia
Novartis Investigative Site
Prague, Czech Republic, Czechia
Novartis Investigative Site
Teplice, Czech Republic, Czechia
Novartis Investigative Site
Varnsdorf, Czech Republic, Czechia
Novartis Investigative Site
Ostrava, CZE, Czechia
Novartis Investigative Site
Pilsen, CZE, Czechia
Novartis Investigative Site
Teplice, CZE, Czechia
Novartis Investigative Site
Břeclav, , Czechia
Novartis Investigative Site
Český Krumlov, , Czechia
Novartis Investigative Site
Kutná Hora, , Czechia
Novartis Investigative Site
Nový Bor, , Czechia
Novartis Investigative Site
Pilsen, , Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Rokycany, , Czechia
Novartis Investigative Site
Tábor, , Czechia
Novartis Investigative Site
Alexandria, , Egypt
Novartis Investigative Site
Tallinn, , Estonia
Novartis Investigative Site
Tartu, , Estonia
Novartis Investigative Site
Peine, Lower Saxony, Germany
Novartis Investigative Site
Koblenz, Rhineland-Palatinate, Germany
Novartis Investigative Site
Ahlen, , Germany
Novartis Investigative Site
Bamberg, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Böhlen, , Germany
Novartis Investigative Site
Delitzsch, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Düren, , Germany
Novartis Investigative Site
Düsseldorf, , Germany
Novartis Investigative Site
Erlangen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Fürstenwalde, , Germany
Novartis Investigative Site
Halle, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Hochstadt, , Germany
Novartis Investigative Site
Kassel, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Ludwigsburg, , Germany
Novartis Investigative Site
Lübeck, , Germany
Novartis Investigative Site
Marburg, , Germany
Novartis Investigative Site
Mittweida, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Neu-Isenburg, , Germany
Novartis Investigative Site
Neuss, , Germany
Novartis Investigative Site
Potsdam, , Germany
Novartis Investigative Site
Potsdam, , Germany
Novartis Investigative Site
Rheine, , Germany
Novartis Investigative Site
Rudersdorf, , Germany
Novartis Investigative Site
Schleswig, , Germany
Novartis Investigative Site
Schwedt, , Germany
Novartis Investigative Site
Weinheim, , Germany
Novartis Investigative Site
Witten, , Germany
Novartis Investigative Site
Ciudad, Gautemala, Guatemala
Novartis Investigative Site
Guatemala City, GTM, Guatemala
Novartis Investigative Site
Guatemala City, GTM, Guatemala
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Budapest, HUN, Hungary
Novartis Investigative Site
Budapest, HUN, Hungary
Novartis Investigative Site
Budapest, HUN, Hungary
Novartis Investigative Site
Budapest, HUN, Hungary
Novartis Investigative Site
Győr, HUN, Hungary
Novartis Investigative Site
Hajdúnánás, HUN, Hungary
Novartis Investigative Site
Makó, HUN, Hungary
Novartis Investigative Site
Miskolc, HUN, Hungary
Novartis Investigative Site
Püspökladány, HUN, Hungary
Novartis Investigative Site
Százhalombatta, HUN, Hungary
Novartis Investigative Site
Balassagyarmat, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Cegléd, , Hungary
Novartis Investigative Site
Csorna, , Hungary
Novartis Investigative Site
Dombóvár, , Hungary
Novartis Investigative Site
Gödöllő, , Hungary
Novartis Investigative Site
Hatvan, , Hungary
Novartis Investigative Site
Komárom, , Hungary
Novartis Investigative Site
Miskolc, , Hungary
Novartis Investigative Site
Mosdós, , Hungary
Novartis Investigative Site
Szarvas, , Hungary
Novartis Investigative Site
Szeged, , Hungary
Novartis Investigative Site
Szeged, , Hungary
Novartis Investigative Site
Szigetvár, , Hungary
Novartis Investigative Site
Szombathely, , Hungary
Novartis Investigative Site
Ahmedabad, Gujarat, India
Novartis Investigative Site
Ahmedabad, Gujarat, India
Novartis Investigative Site
Vadodara, Gujarat, India
Novartis Investigative Site
Mysore, Karnataka, India
Novartis Investigative Site
Kozhikode, Kerala, India
Novartis Investigative Site
Mumbai, Maharashtra, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
Pune, Maharashtra, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Mohali, Punjab, India
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Hyderabad, Telangana, India
Novartis Investigative Site
Lucknow, Uttar Pradesh, India
Novartis Investigative Site
New Delhi, , India
Novartis Investigative Site
Wilton, Cork, Ireland
Novartis Investigative Site
County Limerick, , Ireland
Novartis Investigative Site
Dublin, , Ireland
Novartis Investigative Site
Ichihara, Chiba, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kasuga, Fukuoka, Japan
Novartis Investigative Site
Yanagawa, Fukuoka, Japan
Novartis Investigative Site
Obihiro, Hokkaido, Japan
Novartis Investigative Site
Himeji, Hyōgo, Japan
Novartis Investigative Site
Himeji, Hyōgo, Japan
Novartis Investigative Site
Naka-gun, Ibaraki, Japan
Novartis Investigative Site
Atsugi, Kanagawa, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Okayama, Okayama-ken, Japan
Novartis Investigative Site
Kishiwada, Osaka, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Takatsuki, Osaka, Japan
Novartis Investigative Site
Toyonaka, Osaka, Japan
Novartis Investigative Site
Yao, Osaka, Japan
Novartis Investigative Site
Koshigaya, Saitama, Japan
Novartis Investigative Site
Tokyo, Shibuya Ku, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Chuou-ku, Tokyo, Japan
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan
Novartis Investigative Site
Setagaya-Ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Toshima Ku, Tokyo, Japan
Novartis Investigative Site
Toshima-ku, Tokyo, Japan
Novartis Investigative Site
Riga, LV, Latvia
Novartis Investigative Site
Daugavpils, , Latvia
Novartis Investigative Site
Riga, , Latvia
Novartis Investigative Site
Riga, , Latvia
Novartis Investigative Site
Kaunas, LTU, Lithuania
Novartis Investigative Site
Kaunas, , Lithuania
Novartis Investigative Site
Šiauliai, , Lithuania
Novartis Investigative Site
Utena, , Lithuania
Novartis Investigative Site
Vilnius, , Lithuania
Novartis Investigative Site
Mexicali, Estado de Baja California, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
México, , Mexico
Novartis Investigative Site
Aleksandrow Odzki, Poland, Poland
Novartis Investigative Site
Biaystok, Poland, Poland
Novartis Investigative Site
Lodz, POL, Poland
Novartis Investigative Site
Wejherowo, POL, Poland
Novartis Investigative Site
Bielsko-Biala, , Poland
Novartis Investigative Site
Elblag, , Poland
Novartis Investigative Site
Inowrocław, , Poland
Novartis Investigative Site
Katowice, , Poland
Novartis Investigative Site
Krakow, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Ostrów Wielkopolski, , Poland
Novartis Investigative Site
Sopot, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Zawadzkie, , Poland
Novartis Investigative Site
Iași, Jud Iasi, Romania
Novartis Investigative Site
Constanța, Jud. Constanta, Romania
Novartis Investigative Site
Craiova, Jud.Dolj, Romania
Novartis Investigative Site
Bucharest, ROM, Romania
Novartis Investigative Site
Craiova, ROM, Romania
Novartis Investigative Site
Craiova, ROM, Romania
Novartis Investigative Site
Deva, ROM, Romania
Novartis Investigative Site
Timișoara, ROM, Romania
Novartis Investigative Site
Timișoara, Timiș County, Romania
Novartis Investigative Site
Arad, , Romania
Novartis Investigative Site
Bacau, , Romania
Novartis Investigative Site
Bragadiru, , Romania
Novartis Investigative Site
Brasov, , Romania
Novartis Investigative Site
Brăila, , Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Cluj-Napoca, , Romania
Novartis Investigative Site
Cluj-Napoca, , Romania
Novartis Investigative Site
Codlea, , Romania
Novartis Investigative Site
Craiova, , Romania
Novartis Investigative Site
Râmnicu Vâlcea, , Romania
Novartis Investigative Site
Suceava, , Romania
Novartis Investigative Site
Târgu Mureş, , Romania
Novartis Investigative Site
Yaroslavl, Russian Federation, Russia
Novartis Investigative Site
Chelyabinsk, , Russia
Novartis Investigative Site
Chelyabinsk, , Russia
Novartis Investigative Site
Kazan', , Russia
Novartis Investigative Site
Krasnoyarsk, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
N.Novgorod, , Russia
Novartis Investigative Site
Novosibirsk, , Russia
Novartis Investigative Site
Novosibirsk, , Russia
Novartis Investigative Site
Penza, , Russia
Novartis Investigative Site
Petrozavodsk, , Russia
Novartis Investigative Site
Pyatigorsk, , Russia
Novartis Investigative Site
Ryazan, , Russia
Novartis Investigative Site
Ryazan, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saratov, , Russia
Novartis Investigative Site
Saratov, , Russia
Novartis Investigative Site
Smolensk, , Russia
Novartis Investigative Site
Smolensk, , Russia
Novartis Investigative Site
Stavropol, , Russia
Novartis Investigative Site
Volgograd, , Russia
Novartis Investigative Site
Vologodonsk, , Russia
Novartis Investigative Site
Yaroslavl, , Russia
Novartis Investigative Site
Yaroslavl, , Russia
Novartis Investigative Site
Yaroslavl, , Russia
Novartis Investigative Site
Yekaterinburg, , Russia
Novartis Investigative Site
Belgrade, Serbia, Serbia
Novartis Investigative Site
Belgrade, , Serbia
Novartis Investigative Site
Kamenitz, , Serbia
Novartis Investigative Site
Kragujevac, , Serbia
Novartis Investigative Site
Niš, , Serbia
Novartis Investigative Site
Bardejov, Slovak Republic, Slovakia
Novartis Investigative Site
Bojnice, Slovak Republic, Slovakia
Novartis Investigative Site
Bratislava, Slovak Republic, Slovakia
Novartis Investigative Site
Humenné, Slovak Republic, Slovakia
Novartis Investigative Site
Košice, Slovak Republic, Slovakia
Novartis Investigative Site
Nitra, Slovak Republic, Slovakia
Novartis Investigative Site
Skalica, Slovak Republic, Slovakia
Novartis Investigative Site
Spišská Nová Ves, Slovak Republic, Slovakia
Novartis Investigative Site
Stropkov, Slovak Republic, Slovakia
Novartis Investigative Site
Šurany, Slovak Republic, Slovakia
Novartis Investigative Site
Veľký Meder, Slovak Republic, Slovakia
Novartis Investigative Site
Námestovo, Slovensko, Slovakia
Novartis Investigative Site
Poprad, SVK, Slovakia
Novartis Investigative Site
Bardejov, , Slovakia
Novartis Investigative Site
Bratislava, , Slovakia
Novartis Investigative Site
Čadca, , Slovakia
Novartis Investigative Site
Ilava, , Slovakia
Novartis Investigative Site
Komárno, , Slovakia
Novartis Investigative Site
Košice, , Slovakia
Novartis Investigative Site
Košice, , Slovakia
Novartis Investigative Site
Kráľovský Chlmec, , Slovakia
Novartis Investigative Site
Levice, , Slovakia
Novartis Investigative Site
Liptovský Mikuláš, , Slovakia
Novartis Investigative Site
Prešov, , Slovakia
Novartis Investigative Site
Prievidza, , Slovakia
Novartis Investigative Site
Topoľčany, , Slovakia
Novartis Investigative Site
Žilina, , Slovakia
Novartis Investigative Site
Žilina, , Slovakia
Novartis Investigative Site
Berea, Durban, South Africa
Novartis Investigative Site
Belleville, South Africa, South Africa
Novartis Investigative Site
Panorama, Western Cape, South Africa
Novartis Investigative Site
Cape Town, , South Africa
Novartis Investigative Site
Cape Town, , South Africa
Novartis Investigative Site
Cape Town, , South Africa
Novartis Investigative Site
Wŏnju, Gangwon-do, South Korea
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Cheongju-si, North Chungcheong, South Korea
Novartis Investigative Site
Seoul, Seocho Gu, South Korea
Novartis Investigative Site
Incheon, , South Korea
Novartis Investigative Site
Fowey, Cornwall, United Kingdom
Novartis Investigative Site
Liskeard, Cornwall, United Kingdom
Novartis Investigative Site
Torpoint, Cornwall, United Kingdom
Novartis Investigative Site
Faringdon, Oxfordshire, United Kingdom
Novartis Investigative Site
Bristol, South Gloucestershire, United Kingdom
Novartis Investigative Site
Blackpool, , United Kingdom
Novartis Investigative Site
Denbighshire, , United Kingdom
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Rotherham, , United Kingdom
Novartis Investigative Site
Wiltshire, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Oba 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.
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.
van Zyl-Smit RN, Krull M, Gessner C, Gon Y, Noga O, Richard A, de Los Reyes A, Shu X, Pethe A, Tanase AM, D'Andrea P; PALLADIUM trial investigators. Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):987-999. doi: 10.1016/S2213-2600(20)30178-8. Epub 2020 Jul 9.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-002529-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQVM149B2301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.