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NCT04429516: PAciFy Cough

Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough

Completed Phase 3 Last updated 14 April 2023
What this trial tests

Phase 3 trial testing Morphine Sulfate in Idiopathic Pulmonary Fibrosis in 44 participants. Completed in 21 March 2023.

Timeline
17 December 2020
Primary endpoint
21 March 2023
21 March 2023

Quick facts

Lead sponsorRoyal Brompton & Harefield NHS Foundation Trust
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposetreatment
Enrollment44
Start date17 December 2020
Primary completion21 March 2023
Estimated completion21 March 2023
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Who can join

Adults 40 to 90, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause that results in scarring of the lungs. Cough is reported by 85% of patients with IPF and can be a distressing symptom with significant physical, social and psychological consequences particularly anxiety and depression. The cause of cough in IPF is poorly understood and there are currently no proven effective therapies. Morphine has long been advocated for the suppression of chronic cough in other conditions. While morphine is frequently used as a palliative agent for breathlessness in IPF, its effects on cough have never been tested. The aim of this study is therefore to explore and compare the effect of low dose morphine, one of the few therapies shown to be effective in some patients with otherwise refractory chronic cough, in patients with IPF, to an inactive substance known as a placebo. To make a fair comparison, patients will be randomly allocated to receiving either morphine or placebo in a blinded fashion. This means neither the doctor nor the patient will know which drug they are receiving, and the drugs will appear the same. However, the trial is designed so that you will receive both morphine and placebo, but at different times (this is called a cross-over study). More specifically, you will be given either morphine or placebo for 14 days at a time. In this study, it is hypothesised that compared with placebo, low dose (5mg) controlled release Morphine sulfate (MST) will reduce the number of coughs recorded during a 24hr period in patients with IPF.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Morphine for treatment of cough in idiopathic pulmonary fibrosis (PACIFY COUGH): a prospective, multicentre, randomised, double-blind, placebo-controlled, two-way crossover trial.
    Wu Z, Spencer LG, Banya W, Westoby J, et al · · 2024 · cited 42× · PMID 38237620 · DOI 10.1016/s2213-2600(23)00432-0
  2. Cough in Idiopathic Pulmonary Fibrosis.
    Mann J, Goh NSL, Holland AE, Khor YH. · · 2021 · cited 22× · PMID 36188759 · DOI 10.3389/fresc.2021.751798
  3. COVID-19 and fibrosis: Mechanisms, clinical relevance, and future perspectives.
    Saifi MA, Bansod S, Godugu C. · · 2022 · cited 12× · PMID 36075378 · DOI 10.1016/j.drudis.2022.103345
  4. PAciFy Cough-a multicentre, double-blind, placebo-controlled, crossover trial of morphine sulphate for the treatment of pulmonary Fibrosis Cough.
    Wu Z, Banya W, Chaudhuri N, Jakupovic I, et al · · 2022 · cited 12× · PMID 35236391 · DOI 10.1186/s13063-022-06068-4
  5. ERS International Congress 2023: highlights from the Interstitial Lung Diseases Assembly.
    Fabbri L, Guiot J, Vermant M, Miądlikowska E, et al · · 2024 · cited 1× · PMID 38529351 · DOI 10.1183/23120541.00839-2023
  6. Updates on the Prevalence, Quality of Life, and Management of Chronic Cough in Interstitial Lung Diseases.
    Trushenko NV, Suvorova OA, Schmidt AE, Chikina SY, et al · · 2025 · PMID 40361957 · DOI 10.3390/diagnostics15091139
  7. PAciFy Cough – A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough
    Wu Z, Banya W, Chaudhuri N, Jakupovic I, et al · · 2021 · DOI 10.21203/rs.3.rs-508775/v1

Verify or expand the search:

Other trials of Morphine Sulfate

Trials testing the same drug.

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Currently open trials in the same condition.

Other Royal Brompton & Harefield NHS Foundation Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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