A study to find out if orvepitant is safe to use and reduces the severity of cough in patients with idiopathic pulmonary fibrosis

Phase 2

• Conditions: Chronic cough in patients with lung fibrosis of unknown cause; Respiratory; Chronic cough in patients with idiopathic pulmonary fibrosis

• Registration Number: ISRCTN12372820
• Lead Sponsor: eRRe Therapeutics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Last Update Posted: 24 June 2024
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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 (Hbcorrected 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 antitussive 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

Exclusion Criteria

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:
8.1. Strong or moderate inhibitors of CYP3A4 are not allowed from Screening until 1 week after the last dose of study medication
8.2. Strong or moderate inducers of CYP3A4 are not allowed from Screening until 1 week after the last dose of study medication
8.3. Strong or moderate P-glycoprotein inhibitors are not allowed from Screening until 1 week after the last dose of study medication
8.4. Angiotensin converting enzyme (ACE) inhibitors are not allowed within 3 months of Screening and throughout Part 1
8.5. 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.
8.6. 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
8.7. Immune-suppressant drugs and systemic corticosteroids taken for comorbidities 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
8.8. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weekly average of the daily IPF Coughing Severity Scale score from Baseline (the last 7 days prior to randomisation) to Week 4 (the last 7 days of treatment)