Abstract | BACKGROUND: OBJECTIVES: SEARCH METHODS: We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews. Last search: 27 July 2015.We searched the ongoing trial registry clinicaltrials.gov for any ongoing trials. Latest search for clinicaltrials.gov: 23 October 2015. SELECTION CRITERIA: DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias in the included study. They planned to perform data analysis using Review Manager. MAIN RESULTS: Only one study enrolling 14 participants was eligible for inclusion in the review. The double-blind study compared a daily dose of 600 mg omalizumab or placebo along with twice daily itraconazole and oral corticosteroids, with a maximum daily dose of 400 mg. Treatment lasted six months but the study was terminated prematurely and complete data were not available. We contacted the study investigator and were told that the study was terminated due to the inability to recruit participants into the study despite all reasonable attempts. One or more serious side effects were encountered in six out of nine (66.67%) and one out of five (20%) participants in omalizumab group and placebo group respectively. AUTHORS' CONCLUSIONS:
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Authors | Kana R Jat, Dinesh K Walia, Anju Khairwa |
Journal | The Cochrane database of systematic reviews
(Cochrane Database Syst Rev)
Issue 11
Pg. CD010288
(Nov 04 2015)
ISSN: 1469-493X [Electronic] England |
PMID | 26545165
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review, Systematic Review)
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Chemical References |
- Anti-Allergic Agents
- Antibodies, Anti-Idiotypic
- Antibodies, Monoclonal, Humanized
- Antifungal Agents
- Omalizumab
- Itraconazole
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Topics |
- Anti-Allergic Agents
(adverse effects, therapeutic use)
- Antibodies, Anti-Idiotypic
(adverse effects, therapeutic use)
- Antibodies, Monoclonal, Humanized
(adverse effects, therapeutic use)
- Antifungal Agents
(therapeutic use)
- Aspergillosis, Allergic Bronchopulmonary
(drug therapy, etiology)
- Cystic Fibrosis
(complications)
- Early Termination of Clinical Trials
- Humans
- Itraconazole
(therapeutic use)
- Omalizumab
(adverse effects, therapeutic use)
- Randomized Controlled Trials as Topic
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