Hope for IPF cough: experimental drug shows promise in early trial
NCT ID NCT05185089
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a drug called orvepitant to see if it can reduce chronic coughing in people with idiopathic pulmonary fibrosis (IPF), a serious lung disease. About 80 adults with IPF and persistent cough took either orvepitant or a placebo in two separate periods, and researchers measured changes in cough severity using a daily scale. The goal was to find a safe and effective way to ease this troubling symptom.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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80 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Jun 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Altnagelvin Area Hospital
Londonderry, Northern Ireland, BT47 6SB, United Kingdom
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American Health Research
Charlotte, North Carolina, 28277, United States
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Antrim Area Hospital
Antrim, Northern Ireland, BT41 2RL, United Kingdom
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Baylor University
Dallas, Texas, 75246, United States
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Castle Hill Hospital
Cottingham, Hull, HU16 5JQ, United Kingdom
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Churchill Hospital
Headington, Oxford, OX3 7LE, United Kingdom
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Clear Lake Health
Webster, Texas, 77598, United States
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Erasmus University Medical Centre
Rotterdam, 3015 GD, Netherlands
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Guy's Hospital
London, SE1 9RT, United Kingdom
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Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
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Isala Ziekenhuis
Zwolle, 8025 AB, Netherlands
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Jadestone Clinical Research, LLC
Silver Spring, Maryland, 20904, United States
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Loyola University Chicago
Maywood, Illinois, 60153, United States
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MAC Clinical Research
Prescot, Merseyside, L34 1BH, United Kingdom
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MAC Clinical Research
Barnsley, South Yorkshire, S75 3DL, United Kingdom
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MAC Clinical Research
Leeds, West Yorkshire, LS10 1DU, United Kingdom
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MAC Clinical Research
Manchester, M13 9NQ, United Kingdom
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Medical University of South Carolina
Charleston, South Carolina, 29424, United States
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National Jewish Health
Denver, Colorado, 80206, United States
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Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
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Perth Royal Infirmary
Perth, Perth and Kinross, PH1 1NX, United Kingdom
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PulmonIx, LLC
Greensboro, North Carolina, 27403, United States
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Royal Berkshire Hospital
Reading, Berkshire, RG1 5AN, United Kingdom
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Royal Devon and Exeter Hospital
Exeter, EX2 5DW, United Kingdom
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Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA, United Kingdom
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Royal Papworth Hospital
Cambridge, CB2 0AY, United Kingdom
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Sint Antonius Hospital
Nieuwegein, 3435 CM, Netherlands
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Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
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Temple University
Philadelphia, Pennsylvania, 19140, United States
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University of California
San Francisco, California, 94143, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Southern California
Los Angeles, California, 90033, United States
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University of Utah
Salt Lake City, Utah, 84108, United States
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University of Virginia Health System
Charlottesville, Virginia, 22908, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37204, United States
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Zuyderland Medical Centre
Heerlen, 6419 PC, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can pulmonary fibrosis patients pull hard enough for their inhalers?
- Could skipping the breathing tube ease recovery after throat surgery?
- Can a thousand patient records unlock better care for a rare lung disease?
- Chili compound put to the test as a cough silencer
- Sharper CT scans may solve a lung disease diagnostic puzzle