Phase 3
Completed N=704
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Source: ClinicalTrials.gov NCT03226392 ↗Enrolled (actual)
704
Serious AEs
1.4%
Results posted
Feb 2020
Primary outcomePrimary: Change From Baseline in Pre-dose FEV1 — 0.126; 0.157 Liters — p=0.214
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pre-dose FEV1 |
0.126; 0.157 | 0.214 |
| SECONDARY Change From Baseline in Daytime Asthma Symptom Score |
-0.55; -0.45 | 0.035 sig |
| SECONDARY Change From Baseline in Number of Puffs of SABA Taken Per Day |
-0.89; -0.88 | 0.893 |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score |
0.77; 0.72 | 0.448 |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
- Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
- FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to 20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03226392). 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.