PACIFY Cough
Research type
Research Study
Full title
PAciFy Cough: A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough
IRAS ID
275034
Contact name
Philip Molyneaux
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
Eudract number
2019-003571-19
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
Idiopathic Pulmonary Fibrosis (IPF) is a chronic, progressive, fibrotic lung disease of unknown cause. While current therapies and those in development are understandably targeted at slowing the relentless progression of the disease none attempt to alleviate any of the significant symptoms that patients with IPF suffer from. Cough can be a distressing symptom with significant physical, social and psychological consequences particularly anxiety and depression. The majority of patients with IPF report cough at some point during their disease and it has been associated with a marked impairment in quality of life.
Opiates have long been advocated for the suppression of cough, but the effect on patients specifically with IPF has not been assessed in a randomised clinical trial.
This study will be a randomised, double-blind, placebo controlled, crossover trial evaluating the effect of low dose morphine in patients with IPF. We will assess the effect on cough counts and quality of life. As this is a crossover study, all patients will receive morphine by the end of the study.
Summary of Results
Cough is a major problem for patients with scarring lung disease. We undertook a study to see if morphine, a drug which can help cough in other groups of patients, was able to reduce coughing for patients with scarring lung disease. We enrolled 44 subjects in the study who both received morphine and placebo (sugar tablet) for 14 days in a random order, of which they were unaware. We recorded how many times they coughed at the start and end of each 14 day period using a microphone. When patients were taking the placebo tablet there was very little change in their cough count. However, when they took morphine for 14 days their cough count dropped on average by 39%. This reduction was accompanied by an improvement in the patients reported cough and their overall quality of life too. The low dose of morphine used was well tolerated by the majority of the subjects.
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/0368
Date of REC Opinion
21 May 2020
REC opinion
Further Information Favourable Opinion