Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/27/2016 |
| Start Date: | September 2015 |
| End Date: | March 2016 |
A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 s.c. in Asthma Patients Not Adequately Controlled by Medium- or High-dose ICS Plus LABA With or Without OCS
This study will 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. Safety will
also be assessed. Comparison will be to placebo. Information from this study will inform the
design of future studies.
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. Safety will
also be assessed. Comparison will be to placebo. Information from this study will inform the
design of future studies.
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.
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