Phase 3
Completed N=3,092
Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
Source: ClinicalTrials.gov NCT02571777 ↗Enrolled (actual)
3,092
Serious AEs
7.3%
Results posted
Jul 2020
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26 — 2.050; 2.029; 1.984; 1.953 litre (L) — p=<0.001
◆ Published Evidence
Highly cited
157citations · ~26 / year
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.
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.
Linked Publications (5)
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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.
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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.
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Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses.
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Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26 |
2.050; 2.029; 1.984; 1.953; 1.930 | <0.001 sig |
| SECONDARY Asthma Control Questionnaire (ACQ-7) at Week 26 and Week 52 |
1.542; 1.543; 1.528; 1.614; 1.628; 1.406 | 0.729 |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus Salmeterol/Fluticasone at Week 26 |
2.050; 2.029; 1.984; 1.953; 1.930 | <0.001 sig |
| SECONDARY Trough FEV1 at Week 52 |
2.050; 1.992; 1.965; 1.930; 1.905 | <0.001 sig |
| SECONDARY Pre-dose Forced Vital Capacity (FVC) at Week 4 and Week 12 |
3.091; 3.059; 3.018; 3.020; 2.952; 3.067 | <0.001 sig |
| SECONDARY Trough Forced Expiratory Flow (FEF) Between 25% and 75% of FVC (FEF25-75) at 52 Weeks |
1.354; 1.263; 1.260; 1.214; 1.207 | <0.001 sig |
| SECONDARY Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment |
47.7; 40.5; 29.5; 25.6; 12.5; 39.6 | <0.001 sig |
| SECONDARY Change From Baseline in Percentage of Asthma Symptom-free Days Over 52 Weeks |
22.4; 18.0; 22.2; 18.0; 18.9 | 0.907 |
| SECONDARY Change From Baseline in Percentage of Days With no Daytime Symptoms Over 52 Weeks |
22.5; 17.9; 21.8; 18.0; 18.8 | 0.712 |
| SECONDARY Change From Baseline in Percentage of Nights With no Night-time Awakenings Over 52 Weeks |
18.0; 17.6; 18.4; 16.1; 16.9 | 0.809 |
| SECONDARY Change From Baseline in Percentage of Mornings With no Symptoms on Rising Over 52 Weeks |
19.5; 18.5; 19.9; 15.5; 15.6 | 0.814 |
| SECONDARY Change From Baseline in Percentage of Days Without Rescue Medication Use Over 26 and 52 Weeks |
22.5; 19.5; 23.3; 18.2; 19.6; 25.0 | 0.645 |
| SECONDARY Percentage of Patients Achieving the Minimal Clinically Important Difference (MCID) ACQ ≥ 0.5 at Week 26 and Week 52 |
71.2; 71.7; 74.2; 70.7; 67.4; 78.8 | 0.535 |
| SECONDARY Time to First Hospitalization for Asthma Exacerbation |
367.0; 367.0; 367.0; 367.0; 367.0 | 0.371 |
| SECONDARY Time to First Asthma Exacerbation by Exacerbation Category |
366.0; 366.0; 366.0; 365.0; 365.0; 366.0 | 0.523 |
| SECONDARY Annual Rate of Asthma Exacerbations by Exacerbation Category |
0.46; 0.58; 0.54; 0.67; 0.72; 0.26 | 0.120 |
| SECONDARY Duration in Days of Asthma Exacerbations by Exacerbation Category |
4.5; 5.6; 6.7; 7.1; 8.1; 2.8 | 0.183 |
| SECONDARY Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category |
30.2; 32.5; 31.8; 35.9; 39.7; 21.8 | — |
| SECONDARY Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbation |
367.0; 367.0; 367.0; 367.0; 367.0 | 0.314 |
| SECONDARY Total Amount of Oral Corticosteroid Used (in Prednisone-equivalent mg Doses) to Treat Asthma Exacerbations |
53.4; 72.0; 73.2; 82.5; 86.0 | — |
| SECONDARY Change From Baseline in Percentage of Rescue Medication Free Days Over 26 and 52 Weeks |
22.5; 19.5; 23.3; 18.2; 19.6; 25.0 | 0.645 |
| SECONDARY Asthma Quality of Life Questionnaire (AQLQ) at Week 52 |
5.555; 5.445; 5.535; 5.499; 5.495 | 0.690 |
| SECONDARY Pre-dose FEV1 at Weeks 4 and 12 |
2.032; 1.983; 1.963; 1.950; 1.887; 2.024 | <0.001 sig |
| SECONDARY Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes |
1.4; 2.5; 1.9; 1.6; 1.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of asthma, (GINA 2015) for a period of at least 1 year prior to Visit 1 (Screening).
- Patients who have used medium or high dose of ICS/LABA combinations for asthma for at least 3 months and at stable medium or high doses of ICS/LABA for at least 1 month prior to Visit 1.
- Patients must be symptomatic at screening despite treatment with mid or high stable doses of ICS/LABA. Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (before randomization).
- Patients with documented history of at least one asthma exacerbation which required medical care from a physician, ER visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1, and required systemic corticosteroid treatment.
- Pre-bronchodilator FEV1 of 450 msec for males and > 460 msec for females) and confirmed by a central assessor (these patients should not be rescreened).
- Patients with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
- Patients who have not achieved an acceptable spirometry result at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability. A one-time repeat spirometry is allowed in an ad-hoc visit scheduled as close as possible from the first attempt (but not on the same day) if the spirometry did not qualify due to ATS/ERS criteria at Visit 101 and/or Visit 102. If the patient fails the repeat assessment, the patient may be rescreened once, provided the patient returns to the required treatment as per inclusion criteria 4.
- Patients unable to use the Concept1 dry powder inhaler, Accuhaler or a metered dose inhaler. Spacer devices are not permitted.
- History of alcohol or other substance abuse.
- Patients with a known history of non-compliance to medication or who were unable or unwilling to complete a patient diary or who are unable or unwilling to use Electronic Peak Flow with e-diary device.
- Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).
Data sourced from ClinicalTrials.gov (NCT02571777) 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.