期刊
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
卷 184, 期 1, 页码 92-99出版社
AMER THORACIC SOC
DOI: 10.1164/rccm.201011-1874OC
关键词
clinical trial; endothelin receptor antagonism; high-resolution computed tomography; pulmonary function tests; surgical lung biopsy
资金
- Actelion Pharmaceuticals Ltd (Allschwil, Switzerland)
- Actelion Pharmaceuticals Ltd.
- InterMune
- Immune-Works
- CV Therapeutics
- Boehringer Ingelheim
- Genzyme
- Gilead
- Fibrogen
- Celgene
- Pfizer
- Amgen
- Centocor
- Novartis
- Array Biopharma
- Arresto, Stromedix
- GeNO
- Acelion
- Bayer
- Johnson & Johnson/Centocor
- Perceptive Imaging
- Siemens, Inc.
- Nycomed
- AstraZeneca/Immune
- Elan
- Quark
- Sanofi
- GlaxoSmithKline (GSK)
- AstraZeneca (AZ)
- PARI-Pharma
- Bayer Schering Pharma
- Lilly
- ALK Scherax
Rationale: A previous trial of bosentan in idiopathic pulmonary fibrosis (IPF) showed a trend to delayed IPF worsening or death. Also, improvements in some measures of dyspnea and health-related quality of life were observed. Objectives: To demonstrate that bosentan delays IPF worsening or death. Methods: Prospective, randomized (2:1), double-blind, placebo-controlled, event-driven, parallel-group, morbidity-mortality trial of bosentan in adults with IPF of less than 3 years' duration, confirmed by surgical lung biopsy, and without extensive honeycombing on high-resolution computed tomography. The primary endpoint was time to IPF worsening (a confirmed decrease from baseline in FVC >= 10% and diffusing capacity of the lung for carbon monoxide >= 15%, or acute exacerbation of IPF) or death up to End of Study. Effects of bosentan on health-related quality of life, dyspnea, and the safety and tolerability of bosentan were investigated. Measurements and Main Results: Six hundred sixteen patients were randomized to bosentan (n = 407) or placebo (n = 209). No significant difference between treatment groups was observed in the primary endpoint analysis (hazard ratio, 0.85; 95% confidence interval, 0.66-1.10; P = 0.2110). No treatment effects were observed on health-related quality of life or dyspnea. Some effects of bosentan treatment were observed in changes from baseline to 1 year in FVC and diffusing capacity of the lung for carbon monoxide. The safety profile for bosentan was similar to that observed in other trials. Conclusions: The primary objective in the Bosentan Use in Interstitial Lung Disease-3 trial was not met. Bosentan was well tolerated.
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