Phase 2
Completed N=334
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
Source: ClinicalTrials.gov NCT01836471 ↗Enrolled (actual)
334
Serious AEs
1.5%
Results posted
Mar 2017
Primary outcomePrimary: Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set — 0.05; 0.03 liter — p=0.7269
Summary
The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set |
0.05; 0.03 | 0.7269 |
| SECONDARY Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set |
0.06; 0.01; 0.05 | — |
| SECONDARY Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set |
0.05; 0.03; 0.06; 0.01; 0.05 | 0.9179 |
| SECONDARY Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set |
-0.05; -0.03; -0.25; -0.35; -0.18 | — |
| SECONDARY Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set |
-0.05; -0.03; -0.25; -0.35; -0.18 | 0.7930 |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed
- Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
- Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
- An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
- Demonstration of reversible airway obstruction
Exclusion Criteria
- Pregnant or nursing (lactating) women
- Acute illness other than asthma at the start of the study
- Patients with clinically significant laboratory abnormalities at screening
- Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
- Use of other investigational drugs at the time of enrollment
Data sourced from ClinicalTrials.gov (NCT01836471). 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.