Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion Criteria:

• A diagnosis of allergic asthma, uncontrolled on current medication.

• History of at least 2 asthma exacerbations during the last 1 year

• Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator.

Key Exclusion Criteria:

• Use of tobacco products within the previous 6 months (Social occasional smokers may be included).

• Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.