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
2 other identifiers
interventional
2,216
24 countries
388
Brief Summary
The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants 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
388 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
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedStudy Start
First participant enrolled
December 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2019
CompletedResults Posted
Study results publicly available
March 5, 2020
CompletedMarch 5, 2020
February 1, 2020
2.9 years
September 9, 2015
December 19, 2019
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough Forced Expiratory Volume in One Second (Trough FEV1) 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.
26 weeks
Secondary Outcomes (26)
Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52
Weeks 4, 12, 26 and 52
Trough FEV1 at Week 52
Week 52
Pre-dose FEV1 at Weeks 4 and 12
Weeks 4 (Day 30) and 12 (Day 86)
Post Dose FEV1 (5 Minutes-1 Hour)
Up to Week 52 (Day 364)
Trough Forced Vital Capacity (FVC)
Up to Week 52 (Day 365)
- +21 more secondary outcomes
Study Arms (5)
QMF149 150/160 µg
EXPERIMENTALQMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered once daily (o.d) via Concept1 inhaler in the evening.
QMF149 150/320 µg
EXPERIMENTALQMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening.
MF 400 µg
ACTIVE COMPARATORMometasone furoate (MF) 400 μg was delivered o.d via Twisthaler® in the evening
Salmeterol /fluticasone 50/500 μg
ACTIVE COMPARATORSalmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
MF 800 μg
ACTIVE COMPARATORMF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
Interventions
Eligibility Criteria
You may qualify if:
- Participants with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening)
- 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.
You may not qualify if:
- Participants who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (388)
Novartis Investigative Site
Birmingham, Alabama, 35244, United States
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Los Angeles, California, 90025, United States
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Orange, California, 92868, United States
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Riverside, California, 92506, United States
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San Diego, California, 92117, United States
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San Jose, California, 95117, United States
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Stockton, California, 95207, United States
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Westminster, California, 92683, United States
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Denver, Colorado, 80230, United States
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Miami, Florida, 33144, United States
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Tallahassee, Florida, 32308, United States
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Winter Park, Florida, 32789, United States
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Baltimore, Maryland, 21236, United States
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Waldorf, Maryland, 20602, United States
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North Dartmouth, Massachusetts, 02747-3322, United States
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St Louis, Missouri, 63141, United States
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Bellevue, Nebraska, 68123, United States
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Las Vegas, Nevada, 89119, United States
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Skillman, New Jersey, 08558, United States
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Cortland, New York, 13045, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74136, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97213, United States
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Pittsburgh, Pennsylvania, 15241, United States
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North Charleston, South Carolina, 29407, United States
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Boerne, Texas, 78006, United States
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El Paso, Texas, 79903, United States
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Greenfield, Wisconsin, 53228, United States
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Plovdiv, BGR, 4000, Bulgaria
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Varna, BGR, 9000, Bulgaria
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Vidin, BGR, 3703, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7002, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Troyan Municipality, 5600, Bulgaria
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Beijing, Beijing Municipality, 100044, China
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Beijing, Beijing Municipality, 100730, China
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Fuzhou, Fujian, 350025, China
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Guangzhou, Guangdong, 510120, China
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Haikou, Hainan, 570311, China
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Shijiazhuang, Hebei, 050000, China
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Wuhan, Hubei, 430030, China
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Changsha, Hunan, 410011, China
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Nanjing, Jiangsu, 210006, China
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Nanjing, Jiangsu, 210009, China
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Nanjing, Jiangsu, 210029, 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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Hangzhou, Zhejiang, 310006, China
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Hangzhou, Zhejiang, 310014, China
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Beijing, 100029, China
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Beijing, 100191, China
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Beijing, 100730, China
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Chengdu, 610083, China
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Chongqing, 400038, China
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Guangzhou, 510000, China
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Guangzhou, 510080, China
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Guangzhou, 510180, China
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Nanchang, 330006, China
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Shanghai, 200092, China
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Shanghai, 200433, China
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Tianjin, 300052, China
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Varaždin, HRV, 42000, Croatia
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Zagreb, HRV, 10 000, Croatia
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Petrinja, 44250, Croatia
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Rijeka, 51000, Croatia
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Zadar, 23000, Croatia
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Zagreb, 10000, Croatia
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Beroun, Czech Republic, 266 01, Czechia
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Boskovice, Czech Republic, 680 01, Czechia
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Jablonec nad Nisou, Czech Republic, 466 01, Czechia
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Jindřichův Hradec, Czech Republic, 377 01, Czechia
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Kuřim, Czech Republic, 66434, Czechia
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Prague, Czech Republic, 14800, Czechia
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Teplice, Czech Republic, 415 01, Czechia
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Varnsdorf, Czech Republic, 40747, Czechia
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Ostrava, CZE, 709 00, Czechia
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Pilsen, CZE, 301 00, Czechia
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Teplice, CZE, 415 01, Czechia
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Břeclav, 690 02, Czechia
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Český Krumlov, 381 01, Czechia
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Kutná Hora, 28401, Czechia
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Nový Bor, 47301, Czechia
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Pilsen, 323 00, Czechia
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Prague, 182 00, Czechia
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Rokycany, 337 22, Czechia
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Tábor, 390 01, Czechia
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Alexandria, 21131, Egypt
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Tallinn, 13619, Estonia
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Tartu, 51014, Estonia
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Peine, Lower Saxony, 31224, Germany
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Koblenz, Rhineland-Palatinate, 56068, Germany
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Ahlen, 59229, Germany
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Bamberg, 96049, Germany
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Berlin, 10119, Germany
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Berlin, 10247, Germany
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Berlin, 10367, Germany
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Berlin, 10717, Germany
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Berlin, 10787, Germany
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Berlin, 10969, Germany
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Berlin, 12157, Germany
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Berlin, 12159, Germany
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Berlin, 12203, Germany
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Berlin, 12627, Germany
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Berlin, 13057, Germany
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Berlin, 13086, Germany
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Berlin, 13156, Germany
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Berlin, 13187, Germany
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Bochum, D-44787, Germany
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Bonn, 53119, Germany
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Böhlen, 04564, Germany
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Delitzsch, 04509, Germany
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Dresden, 01069, Germany
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Düren, 52349, Germany
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Düsseldorf, 40211, Germany
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Erlangen, 91052, Germany
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Frankfurt, 60313, Germany
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Frankfurt, 60389, Germany
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Fürstenwalde, 15517, Germany
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Halle, 06108, Germany
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Hamburg, 20354, Germany
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Hamburg, 22143, 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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Hochstadt, 91315, Germany
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Kassel, 34121, Germany
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Leipzig, 04103, Germany
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Leipzig, 04109, Germany
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Leipzig, 04207, Germany
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Leipzig, 04275, Germany
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Ludwigsburg, 71640, Germany
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Lübeck, 23552, Germany
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Marburg, D-35037, Germany
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Mittweida, 09648, Germany
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München, 81377, Germany
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Neu-Isenburg, 63263, Germany
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Neuss, 41462, Germany
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Potsdam, 14467, Germany
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Potsdam, 14469, Germany
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Rheine, 48431, Germany
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Rüdersdorf, 15562, Germany
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Schleswig, 24837, Germany
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Schwedt, 16303, Germany
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Weinheim, 69469, Germany
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Witten, 58452, Germany
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Ciudad, Gautemala, 01010, Guatemala
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Guatemala City, GTM, 01010, Guatemala
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Guatemala City, GTM, 01011, Guatemala
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Guatemala City, 01010, Guatemala
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Guatemala City, 01011, Guatemala
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Guatemala City, 01057, Guatemala
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Budapest, HUN, 1037, Hungary
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Budapest, HUN, 1089, Hungary
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Budapest, HUN, 1117, Hungary
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Budapest, HUN, 1204, Hungary
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Győr, HUN, 9024, Hungary
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Hajdúnánás, HUN, 4080, Hungary
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Makó, HUN, 6900, Hungary
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Miskolc, HUN, 3529, Hungary
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Püspökladány, HUN, 4150, Hungary
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Százhalombatta, HUN, 2440, Hungary
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Balassagyarmat, 2660, Hungary
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Budapest, 1106, Hungary
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Budapest, 1134, Hungary
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Cegléd, 2700, Hungary
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Csorna, H-9300, Hungary
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Dombóvár, 7200, Hungary
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Gödöllő, 2100, Hungary
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Hatvan, 3000, Hungary
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Komárom, 2900, Hungary
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Miskolc, 3526, Hungary
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Mosdós, 7257, Hungary
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Szarvas, 5540, Hungary
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Szeged, 6720, Hungary
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Szeged, 6722, Hungary
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Szigetvár, 7900, Hungary
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Szombathely, 9700, Hungary
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Ahmedabad, Gujarat, 380 008, India
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Ahmedabad, Gujarat, 380016, India
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Vadodara, Gujarat, 390021, India
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Mysore, Karnataka, 570001, India
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Kozhikode, Kerala, 673008, India
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Mumbai, Maharashtra, 400601, India
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Nagpur, Maharashtra, 440010, India
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Nagpur, Maharashtra, 440012, India
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Nagpur, Maharashtra, 440019, India
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Pune, Maharashtra, 411007, India
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New Delhi, National Capital Territory of Delhi, 110007, India
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Mohali, Punjab, 160 062, India
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Jaipur, Rajasthan, 302001, 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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Hyderabad, Telangana, 500082, India
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Lucknow, Uttar Pradesh, 226003, India
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New Delhi, 110029, India
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Wilton, Cork, Ireland
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County Limerick, V94 F858, Ireland
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Dublin, DUBLIN 8, Ireland
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Ichihara, Chiba, 299-0111, Japan
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Fukuoka, Fukuoka, 819-8555, Japan
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Kasuga, Fukuoka, 816-0813, Japan
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Yanagawa, Fukuoka, 832-0059, Japan
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Obihiro, Hokkaido, 080-0013, Japan
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Himeji, Hyōgo, 671-0102, Japan
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Himeji, Hyōgo, 672-8064, Japan
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Naka-gun, Ibaraki, 319-1113, Japan
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Atsugi, Kanagawa, 243-0034, Japan
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Kawasaki, Kanagawa, 255, 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, 236-0004, Japan
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Sendai, Miyagi, 980-0871, Japan
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Okayama, Okayama-ken, 702-8055, Japan
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Kishiwada, Osaka, 596-8501, Japan
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Osaka, Osaka, 530 0001, Japan
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Takatsuki, Osaka, 569-1192, Japan
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Toyonaka, Osaka, Japan
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Yao, Osaka, 581-0011, Japan
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Koshigaya, Saitama, 343-8555, Japan
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Tokyo, Shibuya Ku, 150 0013, Japan
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Chuo Ku, Tokyo, 103 0027, Japan
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Chuou-ku, Tokyo, 103-0028, Japan
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Itabashi-ku, Tokyo, 173-8610, Japan
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Setagaya-Ku, Tokyo, 157-0072, Japan
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Shinjuku-ku, Tokyo, 162-0053, Japan
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Shinjuku-ku, Tokyo, 169-0073, Japan
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Toshima Ku, Tokyo, 170 0003, Japan
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Toshima-ku, Tokyo, 171-0014, Japan
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Riga, LV, 1011, Latvia
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Daugavpils, LV-5401, Latvia
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Riga, LV 1002, Latvia
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Riga, LV-1001, Latvia
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Kaunas, LTU, LT-48259, Lithuania
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Kaunas, LT-49449, Lithuania
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Šiauliai, LT-76231, Lithuania
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Utena, LT-28151, Lithuania
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Vilnius, LT-09108, Lithuania
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Mexicali, Estado de Baja California, 21100, Mexico
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Mexico City, Mexico City, 06700, Mexico
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Mexico City, Mexico City, 14050, Mexico
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México, 07760, Mexico
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Aleksandrow Odzki, Poland, 95-070, Poland
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Biaystok, Poland, 15-430, Poland
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Lodz, POL, 91-110, Poland
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Wejherowo, POL, 84-200, Poland
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Bielsko-Biala, 43-300, Poland
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Elblag, 82-300, Poland
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Inowrocław, 88-100, Poland
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Katowice, 40 085, Poland
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Krakow, 30033, Poland
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Lodz, 90-302, Poland
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Ostrów Wielkopolski, 63-400, Poland
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Sopot, 81-741, Poland
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Warsaw, 01518, Poland
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Zawadzkie, 47-120, Poland
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Iași, Jud Iasi, 700732, Romania
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Constanța, Jud. Constanta, 900002, Romania
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Craiova, Jud.Dolj, 200341, Romania
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Bucharest, ROM, 12071, Romania
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Craiova, ROM, 000000, Romania
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Craiova, ROM, 200712, Romania
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Deva, ROM, 330084, Romania
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Timișoara, ROM, 300298, Romania
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Timișoara, Timiș County, 300310, Romania
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Arad, 310013, Romania
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Bacau, 600114, Romania
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Bragadiru, 077025, Romania
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Brasov, 500051, Romania
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Brăila, 810003, Romania
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Bucharest, 012363, Romania
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Bucharest, 020125, Romania
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Bucharest, 050554, Romania
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Cluj-Napoca, 400275, Romania
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Cluj-Napoca, 400371, Romania
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Codlea, 505100, Romania
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Craiova, 200515, Romania
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Râmnicu Vâlcea, 240564, Romania
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Suceava, 720284, Romania
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Târgu Mureş, 540072, Romania
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Yaroslavl, Russian Federation, 150023, Russia
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Chelyabinsk, 454021, Russia
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Chelyabinsk, 454076, Russia
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Kazan', 420012, Russia
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Krasnoyarsk, 660022, Russia
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Moscow, 105275, Russia
Novartis Investigative Site
Moscow, 119192, Russia
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N.Novgorod, 603126, Russia
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Novosibirsk, 630047, Russia
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Novosibirsk, 630099, Russia
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Penza, 440067, Russia
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Petrozavodsk, 185019, Russia
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Pyatigorsk, 357538, Russia
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Ryazan, 390026, Russia
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Ryazan, 390039, Russia
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Saint Petersburg, 190044, Russia
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Saint Petersburg, 191015, Russia
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Saint Petersburg, 191123, Russia
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Saint Petersburg, 191180, Russia
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Saint Petersburg, 192257, Russia
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Saint Petersburg, 193312, Russia
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Saint Petersburg, 194223, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 196240, Russia
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Saratov, 410012, Russia
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Saratov, 410053, Russia
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Smolensk, 214006, Russia
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Smolensk, 214031, Russia
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Stavropol, 355000, Russia
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Volgograd, 400120, Russia
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Vologodonsk, 347382, Russia
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Yaroslavl, 150000, Russia
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Yaroslavl, 150003, Russia
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Yaroslavl, 150040, Russia
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Yekaterinburg, 620137, Russia
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Belgrade, Serbia, 11000, Serbia
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Belgrade, 11000, Serbia
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Kamenitz, 21204, Serbia
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Kragujevac, 34000, Serbia
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Bardejov, Slovak Republic, 085 01, Slovakia
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Bojnice, Slovak Republic, 972 01, Slovakia
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Bratislava, Slovak Republic, 83103, Slovakia
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Humenné, Slovak Republic, 066 01, Slovakia
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Košice, Slovak Republic, 040 01, Slovakia
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Nitra, Slovak Republic, 949 01, Slovakia
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Skalica, Slovak Republic, 90901, Slovakia
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Spišská Nová Ves, Slovak Republic, 052 01, Slovakia
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Stropkov, Slovak Republic, 09101, Slovakia
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Šurany, Slovak Republic, 942 01, Slovakia
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Veľký Meder, Slovak Republic, 94201, Slovakia
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Námestovo, Slovensko, 02901, Slovakia
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Poprad, SVK, 058 01, Slovakia
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Bardejov, 085 01, Slovakia
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Bratislava, 85101, Slovakia
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Čadca, 022 01, Slovakia
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Ilava, 1901, Slovakia
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Komárno, 945 01, Slovakia
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Košice, 040 01, Slovakia
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Košice, 04001, Slovakia
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Kráľovský Chlmec, 077 01, Slovakia
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Levice, 034 01, Slovakia
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Liptovský Mikuláš, 031 23, Slovakia
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Prešov, 080 01, Slovakia
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Prievidza, 97101, Slovakia
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Topoľčany, 95501, Slovakia
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Žilina, 010 01, Slovakia
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Žilina, 01001, Slovakia
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Berea, Durban, 4001, South Africa
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Belleville, South Africa, 7530, South Africa
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Panorama, Western Cape, 7500, South Africa
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Cape Town, 7531, South Africa
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Cape Town, 7700, South Africa
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Cape Town, 7925, South Africa
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Wŏnju, Gangwon-do, 26427, South Korea
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Bucheon-si, Gyeonggi-do, 14584, South Korea
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Bundang Gu, Gyeonggi-do, 13620, South Korea
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Seoul, Korea, 08308, South Korea
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Incheon, 403-720, South Korea
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Fowey, Cornwall, PL23 1DT, United Kingdom
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Denbighshire, LL181DA, United Kingdom
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London, EC14 7BE, United Kingdom
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London, SE5 8AD, United Kingdom
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Rotherham, S65 1DA, United Kingdom
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Wiltshire, SN15 2SB, United Kingdom
Related Publications (3)
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.
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: 34452934DERIVEDvan 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.
PMID: 32653075DERIVED
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 18, 2015
Study Start
December 29, 2015
Primary Completion
November 21, 2018
Study Completion
June 28, 2019
Last Updated
March 5, 2020
Results First Posted
March 5, 2020
Record last verified: 2020-02