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

Cystic Fibrosis Clinical Trial

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 Bronchopulmonary Aspergillosis (ABPA)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00787917
• Other study ID #: CIGE025A2437
• Status: Terminated
• Phase: Phase 4
• First received: November 7, 2008
• Last updated: September 22, 2011
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: September 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Paul-Ehrlich-InstitutItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Cystic Fibrosis
• Fibrosis
• Pulmonary Aspergillosis

Intervention

Drug:
• Omalizumab
Omalizumab subcutaneous injections of 600 mg daily.
• Placebo
Placebo subcutaneous injections blinded to match experimental arm dosing regimen.
• Itraconazole
Itraconazole twice daily with a maximum daily dose of 400 mg.

Locations

Country	Name	City	State
Belgium	Novartis Investigator Site	Leuven
Germany	Novartis Investigator Site	Berlin
Germany	Novartis Investigator Site	Bonn
Germany	Novartis Investigator Site	Munich
Italy	Novartis Investigator Site	Milan
Italy	Novartis Investigator Site	Rome
Netherlands	Novartis Investigator Site	Nijmegen
Netherlands	Novartis Investigator Site	Utrecht
United Kingdom	Novartis Investigator Site	Cambridge
United Kingdom	Novartis Investigator Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months of blinded treatment	No
Secondary	Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period		6 months, 12 months	No
Secondary	Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment		3 months, 6 months	No
Secondary	Time to Steroid Free State.		12 months	No
Secondary	Change From Baseline in Average Oral Corticosteroid Use.		6 months, 12 months	No
Secondary	Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline		6 months, 12 months	No