NL-OMON41593已完成不适用
Observational study of the effect of Pirfenidone on cough in patients with idiopathic pulmonary fibrosis. - Cough-IPF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Diagnosis of IPF according to ATS/ERS criteria (5), definite and probable patients will be eligible
- •- Written informed consent
- •- Daily cough related to IPF (exclusion of other causes) present > 8 weeks
- •- TLCOc >= 30% and FVC >= 50%
- •If a patient is not able to perform a reliable TLCOc measurement because of for instance coughing; TLCOc should be >= 30 % within the past 6 months and FVC should be >= 50% and no emphysema present on CT and no severe pulmonary hypertension on echo.
- •- Pirfenidone therapy about to be initiated
- •- if a history positive for Gastro Esophageal Reflux (GER), using proton pump inhibitor (PPI) > 4 weeks
排除标准
- •Opiates, antitussive medication, antihistamines, steroids > equivalent of 10 mg prednisone or NAC within two weeks before study
- •- Change of steroid < 10 mg, inhalation steroids within 2 weeks of the study
- •- History of bronchial hyper responsiveness or asthma or relevant airway obstruction (FEV1/FVC < 0.7)
- •- within 6 weeks of the start signs of respiratory tract infection, change of sputum production and fever.
研究者
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