Phase 3
Completed N=1,426
Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium
Source: ClinicalTrials.gov NCT03158311 ↗Enrolled (actual)
1,426
Serious AEs
3.6%
Results posted
Oct 2020
Primary outcomePrimary: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score — 0.715; 0.827; 0.753 Score on a scale — p=<0.001
◆ Published Evidence
Established
21citations · ~5 / year
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.
Summary
The purpose of this trial was to demonstrate that the efficacy of two treatment arms of the fixed-dose combination product QVM149 was non-inferior to the efficacy of the free combination arm of salmeterol/ fluticasone+ tiotropium in uncontrolled moderate to severe asthmatic patients.
The planned duration of treatment in this study was 24 weeks, followed up by a 7-day follow-up period.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score |
0.715; 0.827; 0.753 | <0.001 sig |
| SECONDARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) |
0.246; 0.309; 0.243; 0.251; 0.319; 0.253 | 0.892 |
| SECONDARY Change From Baseline in Asthma Control Questionnaire (ACQ-7) Total Score |
-1.043; -1.098; -1.020; -1.080; -1.172; -1.048 | 0.308 |
| SECONDARY Change From Baseline in AQLQ Total Score |
0.690; 0.755; 0.673 | 0.719 |
| SECONDARY Percentage of Patients Achieving the Minimally Clinically Important Difference (MCID) Decrease From Baseline ACQ-7 ≥ 0.5 |
393; 387; 375 | 0.061 |
| SECONDARY Percentage of Patients Achieving the Minimally Clinically Important Difference (MCID) Change From Baseline AQLQ ≥ 0.5 |
318; 333; 299 | 0.108 |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) |
0.216; 0.272; 0.219; 0.221; 0.275; 0.217 | 0.908 |
| SECONDARY Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75) |
0.290; 0.332; 0.270; 0.291; 0.355; 0.297 | 0.563 |
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of asthma for a period of at least 6 months prior to Visit 1 with current asthma severity ≥ step 4 (GINA 2017).
- Patients who had used ICS/LABA combinations for asthma for at least 3 months and at stable medium or high dose of ICS/LABA for at least 1 month prior to Visit 1.
- Patients were required to be symptomatic at screening despite treatment with medium or high stable doses of ICS/LABA as defined by ACQ-7 score ≥ 1.5 at visits 101 and 201 (randomization visit).
- Patients with history of at least one severe asthma exacerbation which required medical care from a physician, emergency room visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1 and required systemic corticosteroid treatment for at least 3 days including physician guided self-management treatment with oral corticosteroids as part of written asthma action plan.
- Pre-bronchodilator FEV1 of < 85 % of the predicted normal value for the patient after withholding bronchodilators prior to spirometry at both Visit 101 and Visit 201.
- Patients who demonstrated an increase in FEV1 of ≥ 12% and 200 ml.
Exclusion Criteria
- Patients who had a smoking history of greater than 20 pack years.
- Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
- Patients who had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening).
- Patients treated with a LAMA for asthma within 3 months prior to Visit 1.
- Patients who had a respiratory tract infection or clinical significant asthma worsening as defined by Investigator within 4 weeks prior to Visit 1 or between Visit 1 and Visit 201.
Data sourced from ClinicalTrials.gov (NCT03158311) 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.