An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by ABPA
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis; Allergic Bronchopulmonary Aspergillosis
Intervention: Omalizumab (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Novartis Investigator Site
Overall contact:
Novartis, Phone: +41 61 324 1111
Summary
This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic
Bronchopulmonary Aspergillosis in patients with Cystic Fibrosis aged 12 years and older.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from Baseline, after 6 months of treatment, in the use of oral corticosteroids.
Secondary outcome: ABPA exacerbation rates during treatment periods (blinded and open label)Changes in FEV1 from baseline, measured at 3 and 6 months treatment, and in particular changes in FEV1 measured before and after the first dose in both treatment periods. Time to steroid free state. Change from baseline of the average oral corticosteroid use. Proportion of patients responding to omalizumab, as defined by a reduction in oral corticosteroid use of 50% or more.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of Cystic Fibrosis complicated by ABPA
- Oral corticosteroid use
- Age 12 years and older
- Total serum IgE levels ≥ 500IU/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.
Locations and Contacts
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, Leuven, Belgium; Recruiting
No, Phone: +41 61 324 1111
Novartis Investigator Site, Berlin, Germany; Recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, Bonn, Germany; Not yet recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, Hannover, Germany; Not yet recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, Geissen, Germany; Not yet recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, Munich, Germany; Recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, Rome, Italy; Not yet recruiting
Phone: +41 61 324 1111
Novartis Investigator Site, Amsterdam, Netherlands; Not yet recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, Nijmegen, Netherlands; Not yet recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, Utrecht, Netherlands; Not yet recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, London, United Kingdom; Not yet recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigator Site, Newcastle, United Kingdom; Not yet recruiting
Phone: +41 61 324 1111
Novartis Investigator Site, Cambridge, United Kingdom; Not yet recruiting
Phone: +41 61 324 1111
Novartis Investigator Site, Nottingham, United Kingdom; Not yet recruiting
Phone: +41 61 324 1111
Additional Information
Starting date: November 2008
Last updated: August 21, 2009
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