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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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9 January 2017 |
Main ID: |
EUCTR2007-006648-23-IE |
Date of registration:
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15/04/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis
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Scientific title:
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An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis |
Date of first enrolment:
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11/12/2009 |
Target sample size:
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60 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006648-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: There is an optional6 mo open label treatment period, following the first 6 months of blinded t'ment
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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Germany
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Ireland
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Italy
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Netherlands
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Males/females age more than or equal to 12 years 2. Cystic Fibrosis diagnosed by either gene profiling and/or sweat test 3. ABPA previously diagnosed according to the Cystic Fibrosis Foundation Consensus Conference recommendations – minimal diagnostic criteria for diagnosis of ABPA in cystic fibrosis [Stevens, et al 2003] 4. Total serum IgE level of >500 IU/ml 5. Patients who are being treated for ABPA by any oral corticosteroid (OCS) (for at least 8 weeks prior to the first dose) with an OCS entry dose of minimum 5mg/maximum 40mg per day (in prednisolone equivalence) and a history of at least one unsuccessful attempt to taper steroids, defined as in the clinician’s judgment, an ABPA exacerbation during taper, OR patients with a new or recurrent acute ABPA flare, max OCS dose of 20mg. 6. Able to perform spirometry 7. Patients with an FEV1 no lower than 90% of their previous best FEV1 at screening Visit 1 8. FEV1 >40% (>30% is acceptable = 16 years old) of predicted (after 12 hour washout of LABA \ 6 hours of SABA)
Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. History of cancer in the past 10 years (except surgically-cured basal cell or squamous cell skin cancer). 2. Any previous history of anaphylaxis. 3. Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. 4. Female patients of child bearing potential who are pregnant, breast feeding or who are either not surgically sterile, or who are sexually active and not using an acceptable form of contraception. 5. Prior Xolair exposure. 6. Lung or other transplant.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1
Level: LLT
Classification code 10011763
Term: Cystic fibrosis lung
MedDRA version: 9.1
Level: LLT
Classification code 10000244
Term: ABPA
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Intervention(s)
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Trade Name: Xolair Pharmaceutical Form: Powder and solvent for solution for injection Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Primary end point(s): To assess the efficacy of Xolair in adolescent and adult patients with cystic fibrosis (CF) complicated by acute or chronic allergic bronchopulmonary aspergillosis (ABPA) • as measured by the proportion of patients requiring rescue with corticosteroids following 6 months of study treatment • as measured by time to deviation from the protocol prescribed steroid tapering regime
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Main Objective: To assess the efficacy of omalizumab (Xolair) in adolescent and adult patients with cystic fibrosis (CF) complicated by acute or chronic allergic bronchopulmonary aspergillosis (ABPA) •as measured by the proportion of patients requiring rescue with corticosteroids following 6 months of study treatment •as measured by time to deviation from the protocol prescribed steroid tapering regime
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Secondary Objective: To assess: 1. ABPA exacerbation rates during the treatment periods 2. Time to first ABPA exacerbation. 3. Changes in FEV1 from baseline, measured after 3 and 6 months of treatment, in particular changes between FEV1 measured pre and post first dose in both treatment periods. 4. Proportion of patients responding to Xolair treatment, where a responder is defined by a reduction in systemic corticosteroid dose of 50% or more compared to baseline. 5. To measure time to steroid free state, adjusted for baseline steroid dose To assess: 6. Change from baseline in average steroid dose at month 6 7. Proportion of patients in each treatment group whose steroid dose has reduced to 5mg following 6 months of treatment 8.To measure number of steps to reduce the steroid dose to zero (or 5mg) following 6 months of treatment Safety Objective:To explore the safety and tolerability of higher doses of omalizumab in this patient population
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Secondary ID(s)
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CIGE025A2437
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2007-006648-23-DE
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Source(s) of Monetary Support
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Results
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Results available:
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