Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis


About this study

ORV-PF-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with Idiopathic Pulmonary Fibrosis (IPF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria:

- Diagnosis of IPF established according to the 2018 or 2022 joint ATS/ERS/JRS/ALAT
Clinical Practice Guideline

- FEV1/FVC ratio ≥0.65 at the screening visit

- Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25%
within 12 months of the screening visit

- Arterial oxygen saturation on room air or oxygen ≥90% at Screening

- Life expectancy of at least 12 months

- 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

- Mean daily IPF Coughing Severity Scale score ≥5 (after rounding) during the second
week of the baseline assessment period

Key Exclusion Criteria:

- Recent respiratory tract infection (<8 weeks prior to Screening)

- Recent acute exacerbation of IPF (<8 weeks prior to Screening)

- Current smokers or ex-smokers with <6 months' abstinence prior to Screening

- 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

- Mean early morning cough scale score ≥5 and rest of the day cough scale score <5
(after rounding) during the second week of the baseline assessment period (assessed at
Visit 2)

- Cough that is predominantly productive in nature and attributable to lung pathology
such as chronic bronchitis or bronchiectasis

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/20/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vivek Iyer, M.D., M.P.H.

Open for enrollment

Contact information:

Sue Ann Donlinger

(507) 284-9259


More information


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