Clinical Trial: An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmon
Brief 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.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen [ Time Frame: 6 months of blinded treatment ]
Original Primary Outcome: Change from Baseline, after 6 months of treatment, in the use of oral corticosteroids. [ Time Frame: 6 months of blinded treatment ]
Current Secondary Outcome:
- Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period [ Time Frame: 6 months, 12 months ]
- Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment [ Time Frame: 3 months, 6 months ]
- Time to Steroid Free State. [ Time Frame: 12 months ]
- Change From Baseline in Average Oral Corticosteroid Use. [ Time Frame: 6 months, 12 months ]
- Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline [ Time Frame: 6 months, 12 months ]
Original Secondary Outcome:
- ABPA exacerbation rates during treatment periods (blinded and open label) [ Time Frame: 12 months ]
- Changes in FEV1 from baseline, measured at 3 and 6 months treatment, and in particular changes in FEV1 measured before and after the first dose in both treatment periods. [ Time Frame: 12 months ]
- Time to Steroid Free State. [ Time Frame: 12 months ]
- Change from baseline of the average oral corticosteroid use. [ Time Frame: 12 months ]
- Proportion of patients responding to omalizumab, as defined by a reduction in oral corticosteroid use of 50% or more. [ Time Frame: 12 months ]
Information By: Novartis
Dates:
Date Received: November 7, 2008
Date Started: November 2008
Date Completion:
Last Updated: September 22, 2011
Last Verified: September 2011