Clinical trial NCT00787917: An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis
Keywords: Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis
omalizumab
oral corticosteroid use
anti-immunoglobulin E
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-10
Enrollment: 14
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 6 months of blinded treatment
Secondary outcomes:
measure: Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period
timeFrame: 6 months, 12 months
measure: Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment
timeFrame: 3 months, 6 months
measure: Time to Steroid Free State.
timeFrame: 12 months
measure: Change From Baseline in Average Oral Corticosteroid Use.
timeFrame: 6 months, 12 months
measure: Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Novartis Investigator Site
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Bonn
country: Germany
facility: Novartis Investigator Site
city: Munich
country: Germany
facility: Novartis Investigator Site
city: Milan
country: Italy
facility: Novartis Investigator Site
city: Rome
country: Italy
facility: Novartis Investigator Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigator Site
city: Utrecht
country: Netherlands
facility: Novartis Investigator Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigator Site
city: London
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Investigator Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beam KT, Coop CA. Steroid sparing effect of omalizumab in seropositive allergic bronchopulmonary aspergillosis. Allergy Rhinol (Providence). 2015 Jan;6(2):143-5. doi: 10.2500/ar.2015.6.0128.