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

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis	Drug: Omalizumab Drug: Placebo Drug: Itraconazole	Phase 4

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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Aspergillosis Cystic Fibrosis Steroids

Drug Information available for: Itraconazole Omalizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Time to Steroid Free State. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change From Baseline in Average Oral Corticosteroid Use. [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	November 2008
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Omalizumab Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Participants who completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.	Drug: Omalizumab Omalizumab subcutaneous injections of 600 mg daily. Other Names: Xolair IGE025 Drug: Itraconazole Itraconazole twice daily with a maximum daily dose of 400 mg. Other Name: Sporanox
Placebo Comparator: Placebo Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.	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. Other Name: Sporanox

Arms

Assigned Interventions

Experimental: Omalizumab

Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.

Participants who completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.

Drug: Omalizumab

Omalizumab subcutaneous injections of 600 mg daily.

Other Names:

Xolair
IGE025

Drug: Itraconazole

Itraconazole twice daily with a maximum daily dose of 400 mg.

Other Name: Sporanox

Placebo Comparator: Placebo

Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.

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.

Other Name: Sporanox

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787917

Locations

Belgium
Novartis Investigator Site
Leuven, Belgium
Germany
Novartis Investigator Site
Berlin, Germany
Novartis Investigator Site
Bonn, Germany
Novartis Investigator Site
Munich, Germany
Italy
Novartis Investigator Site
Milan, Italy
Novartis Investigator Site
Rome, Italy
Netherlands
Novartis Investigator Site
Nijmegen, Netherlands
Novartis Investigator Site
Utrecht, Netherlands
United Kingdom
Novartis Investigator Site
Cambridge, United Kingdom
Novartis Investigator Site
London, United Kingdom

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Principal Investigator:

Novartis

Novartis Investigator Site

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00787917 History of Changes
Other Study ID Numbers:	CIGE025A2437
Study First Received:	November 7, 2008
Results First Received:	July 11, 2011
Last Updated:	September 22, 2011
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Paul-Ehrlich-Institut Italy: Ministry of Health

Keywords provided by Novartis:

Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis
omalizumab
oral corticosteroid use
anti-immunoglobulin E

Additional relevant MeSH terms:

Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Cystic Fibrosis
Fibrosis
Pulmonary Aspergillosis
Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pancreatic Diseases

Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Itraconazole
Hydroxyitraconazole
Omalizumab
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 19, 2013