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Could morphine finally silence the hacking cough of IPF?

NCT ID NCT04429516

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether low-dose morphine can reduce chronic coughing in people with idiopathic pulmonary fibrosis (IPF), a lung-scarring disease. Forty-four participants received either morphine or a placebo for two weeks, then switched after a week off. The goal was to see if morphine lowered cough counts and improved quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
morphine sulfate
What this could lead to
If it works, this could provide a new option to ease chronic coughing in people with IPF, improving their daily comfort and quality of life.
What could go wrong
This is a small, early-phase trial with only 44 participants. Morphine may cause side effects like drowsiness or constipation, and the cough relief might not be better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

44 people

The number who actually took part.

Started

Dec 2020

Finished

Mar 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 90 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Self-reported cough (\> 8 weeks), with cough VAS ≥ 30/100 2. A diagnosis of IPF within 5 years prior to the screening visit, as per applicable ATS/ERS/JRS/ALAT guidelines, in line with hospital records. 3. Age 3.1. Male and female participants aged ≥ 40 - 90 years at the time of signing informed consent 4. Sex: 4.1 Male participants: A male participant must agree to use contraception as detailed in Appendix 2 of this protocol during the study and for at least 90 days after the follow-up visit, and refrain from donating sperm during this period 4.2 Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP) 5. Meeting all of the following criteria during the screening period: FVC ≥ 45% predicted of normal, Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7, DLCO corrected for Hb ≥30% predicted of normal. 6. The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator determined within 24 months of the study screening visit) 7. Written informed consent. Exclusion criteria: 1. Treatment with immunosuppressive therapy or antibiotics within last 4 weeks. A stable dose of corticosteroids equivalent to prednisolone of 10 mg per day or less, if used for an indication other than pulmonary disease will be permitted 2. Current smoker 3. History of alcohol and drug(s) addiction 4. Regular use of sedative therapies 5. Acute IPF exacerbation within 6 months prior to screening and/or during the screening period. 6. Concurrent use of pirfenidone or Nintedanib, unless receiving a stable dose for at least 8 weeks prior to screening 7. Use of ACE inhibitors 8. Patients with co-existent conditions know to be associated with the development of fibrotic lung disease. This includes: connective tissue disease, (plural plaques, mesothelioma), granulomatous disease including sarcoidosis. Patient with auto-immune profile considered diagnostic for a specific connective tissue disease will be excluded, even in the absence of systemic symptoms. Non-specific rises in auto antibodies e.g. rheumatoid factors, anti-nuclear antibody etc. will not be used to exclude individuals from the study. 9. Significant other organ co-morbidity including hepatic or renal impairment and pulmonary hypertension (investigator determined). 10. Significant coronary artery disease (myocardial infarction within 6 months or ongoing unstable angina within 4 weeks of screening visit) or congestive cardiac failure based on clinical examination 11. Patients as significant risk of side effects, intolerance or allergy to morphine 12. Pregnant and breastfeeding patients, or women or child-bearing potential, not using a reliable contraceptive method (see Appendix 2). A urine pregnancy test will be performed in females of child-bearing potential at the initial study visit. 13. Unable to provide informed written consent 14. Predicted life expectancy \< 6 months 15. Use of long-term oxygen therapy. Use of ambulatory oxygen will be permitted. 16. Current or use of opiates within 14 days of the screening visit.

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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

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.