NL-OMON51793尚未招募2 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 - ORV-PF-01 / IPF COMFORT
eRRe Therapeutics Ltd0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 visit1.
- •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 nintedanib2, the dose must have been stable dose
- •for at least 3 months prior to Screening.
- •11. Female subjects must not be of child-bearing potential (i.e., they must be
- •surgically sterilised or post-menopausal3).
- •12. Male subjects who have partners of child-bearing potential must agree to
- •use a condom from the Baseline visit until 30 days after the last dose of study
- •medication.
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
- •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 (World Health
- •Organisation functional class III or IV [and where functional limitation is due
- •to PAH rather than IPF]).
- •8. A history of clinically relevant drug or alcohol abuse [according to
- •Diagnostic and Statistical Manual of Mental Disorders 5 criteria (or later
- •edition if applicable)] within 6 months before Screening.
- •9. Any other clinically significant or unstable medical or psychiatric
- •condition that would, in the opinion of the investigator, interfere with the
- •subject*s ability to participate safely in the study.
- •10. Any malignancy in the past 5 years unless non-invasive and in remission.
- •Any malignancy diagnosed more than 5 years prior to screening must have been in
- •complete remission for at least 5 years. Written approval must be obtained from
- •the Sponsor for a subject with any history of malignancy.
- •11. Any clinically significant abnormal laboratory test result(s), measured at
- •12. 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 the study;
- •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 the study. 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 e
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