Safety and Efficacy of QAW039 in Sputum Eosinophilia and Persistent Asthma
|ClinicalTrials.gov Identifier: NCT01545726|
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : October 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: QAW039 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo-controlled Study Examining the Effect of Orally Administered QAW039 on Sputum Eosinophil Levels and Other Efficacy Outcomes in Patients With Sputum Eosinophilia and Persistent Asthma|
|Study Start Date :||February 2012|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
Eligible patients will receive QAW039 po 450 mg daily dose.
QAW039 was supplied as capsules for oral administration.
Placebo Comparator: Placebo
Placebo to QAW039 (oral capsules) will be administered to match QAW039 schedule.
Placebo was supplied as capsules for oral administration.
- Change from baseline in sputum eosinophil percentage at week 12 (baseline measurement is defined as sputum eosinophil percentage at Day1 prior to the first dosing). [ Time Frame: Visit 3 (day 1); Visit 5 (day 84) ]Sputum induction is performed through the inhalation of hypertonic saline. Sputum is collected and assessed for differential cellular content (absolute numbers and percentages). The primary variable will be summarized by treatment and analyzed using an ANCOVA model with treatment as the fixed effect and the respective baseline value as the covariate.
- Change from baseline to week 12 in Asthma Control Questionnaire (ACQ) [ Time Frame: Visit 3 (day 1); Visit 5 (day 84) ]Participants complete the Asthma Control Questionnaire (ACQ). The ACQ has 7 equally weighted items; 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber Forced Expiratory Volume in one second (FEV1) % predicted. Items 1-6 are scored along a 7 point response scale, where 0 = good control and 6 = poor control. The 7th item on % predicted FEV1 (pre-bronchodilator) is scored by clinic staff on a 7 point scale. Secondary variables are summarized by treatment and analyzed using ANCOVA model with treatment as the fixed effect and the respective baseline value as covariate.
- Safety and tolerability of QAW039 in patients with moderate to severe asthma [ Time Frame: Visit 2 (day -14); Visit 3 (day 1); Visit 4 (day 42); Visit 5 (day 84); Visit 6 (day 126) ]All safety endpoints (including adverse events, laboratory data, vital signs and ECG) will be summarized by treatment group for all patients in the safety population. All data will be included in the analysis regardless of rescue medication use.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545726
|Novartis Investigative Site|
|Leicester, United Kingdom, LE3 9QP|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|