Trials / Terminated
TerminatedNCT00787917
An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omalizumab | Omalizumab subcutaneous injections of 600 mg daily. |
| DRUG | Placebo | Placebo subcutaneous injections blinded to match experimental arm dosing regimen. |
| DRUG | Itraconazole | Itraconazole twice daily with a maximum daily dose of 400 mg. |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2010-07-01
- Completion
- 2010-07-01
- First posted
- 2008-11-10
- Last updated
- 2011-09-26
- Results posted
- 2011-08-04
Locations
10 sites across 5 countries: Belgium, Germany, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT00787917. Inclusion in this directory is not an endorsement.