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

ovartis Pharma Services AG0 个研究点目标入组 60 人开始时间: 2008年8月15日最近更新: 2012年3月19日

试验速览

暂无简介。

•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

•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.

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