Clinical Trial: Safety and Efficacy of QAW039 in Sputum Eosinophilia and Persistent Asthma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Eosino

Brief Summary: This study will assess the safety and efficacy of QAW039 when added to current therapy in patients that have sputum eosinophilia and persistent asthma.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Change from baseline to week 12 in Asthma Control Questionnaire (ACQ) [ Time Frame: Visit 3 (day 1); Visit 5 (day 84) ]

    The ACQ is completed by the participant. The ACQ consists of 7 equally weighted items; 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (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.

    The secondary variables 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.

  • To assess the 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.


Information By: Novartis

Dates:
Date Received: March 1, 2012
Date Started: February 2012
Date Completion:
Last Updated: October 8, 2013
Last Verified: October 2013