NL-OMON51409已完成不适用
A multi-center, longitudinal 12-week pilot study to evaluate cough severity and its impact, utilizing a next generation cough monitor, in participants with idiopathic pulmonary fibrosis (IPF) or Non IPF Pulmonary Fibrosis - Monitoring cough in people with pulmonary fibrosis with a wearable device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of signed informed consent in writing prior to study data
- •2. Subject aged 18 years or over
- •3. Subject diagnosed with Non IPF Pulmonary Fibrosis (>10% fibrosis on HRCT by
- •principal investigator assessment) or IPF as per ATS/ERS/JRS/ALAT Guidelines
- •[P22-03204] within the past 12 months
- •4. FVC > 40% predicted at baseline visit
- •5. Life expectancy > 6 months (per assessment of treating physician)
排除标准
- •1. Current smokers
- •2. URI or LRTI (including COVID-19 infection) within 4 weeks of screening visit
- •3. Airflow obstruction (FEV1/FVC < 70%) at baseline or known history of
- •significant
- •spirometry response to bronchodilator
- •4. Cough due to etiology other than ILD (e.g., allergic rhinitis, GERD)
- •5. Other respiratory disorders including, but not limited to, a current
- •diagnosis of any
- •obstructive disease including chronic obstructive pulmonary disease (COPD) and
- •asthma, active tuberculosis, lung cancer in treatment or in medical history,
- •apnea, known alpha-1 antitrypsin deficiency, cor pulmonale, clinically
- •significant
- •pulmonary hypertension, clinically significant bronchiectasis, or other active
- •pulmonary diseases.
- •6. Initiation or change in dose or type of anti-tussive medication,
- •angiotensin-converting
- •enzyme (ACE) inhibitors, opiates, and systemic or inhaled (excluding intranasal)
- •corticosteroids in the 4 weeks prior to study entry
- •7. Subject with ILD exacerbation as defined by investigators within 4 weeks
- •study entry
研究者
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