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

NCT00787917 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-09-26

Study results available
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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.

Conditions

Interventions

DRUG

Omalizumab

Omalizumab subcutaneous injections of 600 mg daily.

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis Investigator Site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Belgium
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787917 on ClinicalTrials.gov