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

September 22, 2011 updated by: Novartis Pharmaceuticals

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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: Itraconazole
Itraconazole twice daily with a maximum daily dose of 400 mg.
Other Names:
  • Sporanox
Drug: Placebo
Placebo subcutaneous injections blinded to match experimental arm dosing regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months of blinded treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period
Time Frame: 6 months, 12 months
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
3 months, 6 months
Time to Steroid Free State.
Time Frame: 12 months
12 months
Change From Baseline in Average Oral Corticosteroid Use.
Time Frame: 6 months, 12 months
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
6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (Estimate)

November 10, 2008

Study Record Updates

Last Update Posted (Estimate)

September 26, 2011

Last Update Submitted That Met QC Criteria

September 22, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIGE025A2437

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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