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 sites108 target enrollmentJune 1, 2022

Overview

No summary available.

Registry

who.int

Start Date

June 1, 2022

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

eRRe Therapeutics Ltd

•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

•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