Trials / Completed
CompletedNCT00801853
A Study of the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients, AEROTRIAL
A Phase IIb Study to Investigate the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients Not Fully Controlled on Current Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 424 (estimated)
- Sponsor
- Aerovance, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A multi-center, Phase IIb, double-blind, randomized, placebo controlled, parallel-group, repeated-dose study in male and female patients with moderate to severe asthma in which patients will be stabilized on AEROVANT then doses of inhaled corticosteroids and LABA will be tapered. The hypothesis is that AEROVANT will improve asthma symptom control and decrease the need for inhaled corticosteroids and LABA, thus improving exacerbation incidence compared to placebo. Incidence of asthma exacerbation is the primary endpoint.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aerovant | Aerovant 1mg bid (dry powder) |
| DRUG | Aerovant | Aerovant 3mg bid (dry powder) |
| DRUG | Aerovant | Aerovant 10mg bid (dry powder) |
| OTHER | placebo | placebo control (dry powder) |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2008-12-04
- Last updated
- 2011-01-27
Locations
71 sites across 4 countries: United States, Hungary, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT00801853. Inclusion in this directory is not an endorsement.