Omalizumab (Xolair) in Cystic Fibrosis complicated by ABPA

• Research type

  Research Study

• Full title

  An exploratory, randomised, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis (ABPA).

• IRAS ID

  6742

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2007-006648-23

• Clinicaltrials.gov Identifier

  00787917

• Research summary

  <span style="color: We want to assess if taking Xolair will help patients with cystic fibrosis (CF) complicated by an allergic reaction in the lungs - allergic bronchopulmonary aspergillosis (ABPA) to: <ul> <li style="color: stop (or reduce)steroid pills (usually used to control this problem)</li> <li style="color: improve breathing as measured by lung function tests (spirometry)</li> <li style="color: reduce the number of times a patient gets an ABPA exacerbation (flare)</li> <li style="color: be safe and acceptable for patients</li></ul>This study is being sponsored by Novartis. Xolair is an approved drug for patients aged >12 years old with moderate to severe asthma. ABPA gives similar symptoms to asthma ie: wheezing. Doctors have given Xolair to patients with CF and ABPA with encouraging results, but this is the first time it will be tested in a research study in patients with CF & ABPA. At present the only proven effective treatment for these patients is steroids, which have undesirable side effects, particularly in growing youngsters. We plan to recruit 60 patients in Europe, with CF and either chronic or acute ABPA aged > 12 years old. For 6 months patients will receive either Xolair or placebo (2:1) and then everyone in the study will be offered treatment with Xolair for the last 6 months of the study. This is so all patients get the chance to be treated with Xolair. Investigations include: blood tests, urine tests, spirometry and FENO measurements (breathing tests) and quality of life questionnaires.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  08/H0711/115

• Date of REC Opinion

  27 Feb 2009

• REC opinion

  Further Information Favourable Opinion