CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44 enrolled
Drug / intervention
Morphine Sulfate +1 moredrug
Likely dose
Morphine Sulfate 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04429516
NCT04429516Phase 3Completed

PAciFy Cough: A Multicentre, Double Blind, Placebo Controlled, Crossover Trial of Morphine Sulfate for the Treatment of PulmonAry Fibrosis Cough

Royal Brompton & Harefield NHS Foundation Trust·interventional·Posted Jun 12, 2020·Updated May 7, 2026

In Brief

A Phase 3 clinical trial evaluating Morphine Sulfate and Placebo oral tablet for Idiopathic Pulmonary Fibrosis. Completed, enrolled 44 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 12, 2020
Enrollment StartDec 17, 2020
Primary CompletionMar 21, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.1 years ago

Interventions

Morphine Sulfatedrug

over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.

Placebo oral tabletdrug

capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily