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
Source: ClinicalTrials.gov NCT02554786 ↗Summary
Linked Publications (3)
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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.
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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.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26 |
2.383; 2.387; 2.250; 2.176; 2.346 | <0.001 sig |
| SECONDARY Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52 |
1.486; 1.533; 1.659; 1.730; 1.541; 1.394 | <0.001 sig |
| SECONDARY Trough FEV1 at Week 52 |
2.386; 2.357; 2.249; 2.148; 2.338 | <0.001 sig |
| SECONDARY Pre-dose FEV1 at Weeks 4 and 12 |
2.369; 2.367; 2.237; 2.171; 0.2333; 2.368 | <0.001 sig |
| SECONDARY Post Dose FEV1 (5 Minutes-1 Hour) |
2.279; 2.270; 2.138; 2.118; 2.224; 2.321 | <0.001 sig |
| SECONDARY Trough Forced Vital Capacity (FVC) |
3.342; 3.342; 3.256; 3.203; 3.344; 3.372 | <0.001 sig |
| SECONDARY Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75) |
1.644; 1.617; 1.455; 1.406; 1.662; 1.775 | <0.001 sig |
| SECONDARY Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment |
42.4; 38.1; 12.8; 5.9; 29.1; 32.5 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52 |
76.4; 76.2; 72.3; 66.9; 75.9; 77.7 | 0.094 |
| SECONDARY Change From Baseline in Percentage of Asthma Symptoms Free Days |
28.3; 28.4; 22.5; 19.3; 24.9 | 0.012 sig |
| SECONDARY Change Form Baseline in Percentage of Days With no Daytime Symptoms |
28.0; 28.0; 23.0; 20.0; 24.8 | 0.026 sig |
| SECONDARY Change From Baseline in Percentage of Nights With no Night-time Awakenings |
17.0; 16.4; 14.2; 12.5; 16.1 | 0.104 |
| SECONDARY Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening |
25.5; 22.9; 19.1; 14.1; 20.7 | 0.003 sig |
| SECONDARY Rescue Medication Usage |
-0.38; -0.27; -0.26; -0.19; -0.34; -0.57 | 0.001 sig |
| SECONDARY Time to First Asthma Exacerbation by Exacerbation Category |
366.0; 366.0; 366.0; 364.0; 366.0; 367 | <0.001 sig |
| SECONDARY Time to First Hospitalization for Asthma Exacerbation |
367.0; 367.0; 367.0; 366.0; 367.0 | 0.337 |
| SECONDARY Annual Rate of Asthma Exacerbations by Exacerbation Category |
0.25; 0.27; 0.39; 0.56; 0.27; 0.13 | 0.008 sig |
| SECONDARY Duration in Days of Asthma Exacerbations by Exacerbation Category |
2.6; 3.0; 3.7; 5.8; 3.1; 1.3 | <0.001 sig |
| SECONDARY Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category |
14.9; 16.9; 26.1; 32.5; 19.1; 8.1 | — |
| SECONDARY Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations |
367.0; 367.0; 367.0; 366.0; 367.0 | 0.222 |
| SECONDARY Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations |
0.2; 0; 0.9; 1.6; 0.5 | — |
| SECONDARY Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations |
26.0; 29.9; 28.0; 47.8; 26.9 | — |
| SECONDARY Change From Baseline in Percentage of Rescue Medication Free Days |
31.5; 27.4; 21.4; 19.1; 27.4; 33.1 | < 0.001 sig |
| SECONDARY Asthma Quality of Life Questionnaire (AQLQ) |
5.560; 5.498; 5.413; 5.374; 5.515; 5.618 | 0.002 sig |
| SECONDARY Trough FEV1 Measured After 26 Weeks of Treatment |
2.383; 2.387; 2.250; 2.176; 2.346 | 0.101 |
| SECONDARY Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes |
0.7; 0.5; 1.6; 1.8; 0.5 | — |
| SECONDARY Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
64.6; 66.8; 70.0; 72.2; 65.3; 4.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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 =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 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 Immunothe
Data sourced from ClinicalTrials.gov (NCT02554786) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.