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
Conditions
Interventions
Trade Name: Xolair 150 mg Pulver und Injektionslösung zur Herstellung einer Injektionslösung
Product Name: Xolair
Product Code: IGE025
Pharmaceutical Form: Powder and solvent for solution for injectio
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 6. Patients with an FEV1 no lower than 90% of their previous best FEV1 at Screening Visit 7. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. New exclusion criteria (amendment 04): 13. History of elevated liver enzymes (>3x ULN) or active liver disease, or patients who have experienced liver toxicity with other drugs. 14. Elevated liver enzymes (>3x ULN) at screening. 15. Patients treated with contraindicated drugs as listed in the Itraconazole SPC, i.e. cisapride, pimozide, quinidine or dofetilide. 16. History, or active condition of congestive heart failure or evidence of ventricular dysfunction. 17. History of hypersensitivity to itraconazole and/or oral corticosteroid tablets (or any excipients) Additional exclusion criteria are outlined in the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;Secondary Objective: To assess: 1. ABPA exacerbation rates during the treatment periods 2. 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. 3. 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. 4. To measure time to steroid free state. To assess: 5. Change from baseline in average steroid dose. 6. Proportion of patients in each treatment group whose steroid dose has reduced to 5mg following 6 months of treatment. To measure: 7. Number of steps to reduce steroid dose to zero (or 5mg or less) following 6 months of treatment 8. Immunogenicity 9. PK/PD Safety Objective:To explore the safety and tolerability of higher doses of omalizumab in this patient population ;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 | — |
Countries
Belgium, Germany, Ireland, Italy, Netherlands, United Kingdom
Outcome results
None listed