EUCTR2021-006278-22-NL进行中（未招募）1 期
A DOUBLE-BLIND, RANDOMISED, PLACEBO CONTROLLED, TWO PERIOD CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORVEPITANT IN CHRONIC COUGH IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
eRRe Therapeutics Ltd0 个研究点目标入组 108 人开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects =40 years of age
- •2. Able to understand and comply with the requirements of the study and give informed consent
- •3. Diagnosis of IPF established according to the 2018 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline
- •4. FEV1/FVC ratio =0.65 at the screening visit
- •5. Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) =25% within 12 months of the screening visit
- •6. Arterial oxygen saturation on room air or oxygen =90% at Screening
- •7. Life expectancy of at least 12 months
- •8. Cough that is attributed to IPF, which has not responded to anti-tussive treatment, and which has been present for at least 8 weeks prior to screening
- •9. Mean daily IPF Coughing Severity Scale score =5.0 during the second week of the baseline assessment period (assessed at Visit 2)
- •10. If taking pirfenidone or nintedanib, the dose must have been stable dose for at least 3 months prior to Screening
- •Are the trial subjects under 18? no
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •1. Recent respiratory tract infection (<8 weeks prior to Screening)
- •2. Recent acute exacerbation of IPF (<8 weeks prior to Screening)
- •3. Current smokers or ex-smokers with <6 months’ abstinence prior to Screening
- •4. Emphysema =50% on high-resolution computed tomography, or the extent of emphysema is greater than the extent of fibrosis according to the reported results of the most recent scan
- •5. Mean early morning cough scale score =5.0 and rest of the day cough scale score <5 during the second week of the baseline assessment period (assessed at Visit 2)
- •6. Cough that is predominantly productive in nature and attributable to lung pathology such as chronic bronchitis or bronchiectasis
- •7. Known clinically significant pulmonary hypertension
- •8. Inability to comply with the use of prohibited and allowed medications as described below:
- •a. Strong or moderate inhibitors of CYP3A4 are not allowed from Screening until 1 week after the last dose of study medication
- •b. Strong or moderate inducers of CYP3A4 are not allowed from Screening until 1 week after the last dose of study medication
- •c. Strong or moderate P-glycoprotein inhibitors are not allowed from Screening until 1 week after the last dose of study medication
- •d. Angiotensin converting enzyme (ACE) inhibitors are not allowed within 3 months of Screening and throughout Part 1
- •e. Other treatments for cough management (including opioids, dextromethorphan, gabapentin, pregabalin, baclofen, antihistamines, thalidomide or tricyclic antidepressants (e.g. amitriptyline)) are not allowed from 4 weeks before the Baseline visit until Visit 8. Medications in these classes may be continued provided they have been prescribed solely for the management of another comorbidity and the dose has been stable for at least 4 weeks before the screening visit.
- •f. The use of other NK1 antagonists (eg aprepitant, fosaprepitant, rolapitant) is not permitted for any reason from 4 weeks before the Baseline visit
- •until completion of Visit 8
- •g. Immune-suppressant drugs and systemic corticosteroids taken for co-morbidities are permitted provided the dose has been stable for at least 2 weeks before the screening visit and they are expected to be used at this dose throughout Part 1. Any other use is prohibited
- •h. Supplemental oxygen is permitted provided it has been used for at least 2 weeks before the screening visit and is expected to be used throughout
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