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

Phase 2

Not yet recruiting

Conditions: chronic cough
idiopathic pulmonary fibrosis
10037454

Registration Number: NL-OMON51793

Lead Sponsor: eRRe Therapeutics Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

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 (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.

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 (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
Screening.
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the mean change from Baseline (the last 7 days prior to<br /><br>randomisation) to Week 4 (the last 7 days of treatment) in weekly average of<br /><br>the daily IPF Coughing Severity Scale score.</p><br>

Secondary Outcome Measures