An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00787917
• Date of registration: 07/11/2008
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
• Scientific title: 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)
• Date of first enrolment: November 2008
• Target sample size: 14
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00787917
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Belgium, Germany, Italy, Netherlands, United Kingdom

Contacts

• Name: Novartis
• Affiliation: Novartis Investigator Site

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of Cystic Fibrosis complicated by Allergic Bronchopulmonary Aspergillosis
(ABPA)

- Oral corticosteroid use for ABPA flare

- Age 12 years and older (except for Italy; = 18 years)

- Total serum IgE levels = 500 IU/mL

Exclusion Criteria:

- History of cancer in the last 10 years.

- History of severe allergic reactions

- Pregnant and lactating women

- Prior use of Xolair

Other protocol-defined inclusion/exclusion criteria may apply.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Allergic Bronchopulmonary Aspergillosis

Cystic Fibrosis

Intervention(s)

Drug: Omalizumab

Drug: Placebo

Drug: Itraconazole

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Change From Baseline in Average Oral Corticosteroid Use. [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]

Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period [Time Frame: 6 months, 12 months]

Time to Steroid Free State. [Time Frame: 12 months]

Secondary ID(s)

CIGE025A2437

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/08/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00787917