A phase 3 clinical trial testing morphine sulphate for the treatment of cough in idiopathic pulmonary fibrosis (IPF) is now recruiting participants.
The multicenter, double-blind, placebo-controlled, crossover study called PAciFy Cough started on December 17, 2020, and is estimated to be completed in August 2022. It aims to recruit an estimated 44 IPF patients aged 40 to 90 years with a self-reported cough lasting more than 8 weeks.
Participants will either receive 5 mg of oral morphine sulphate twice per day for 14 days or a placebo. After a 7-day wash-out period, participants will cross over to the other arm of the study.
The primary outcome measure is the percent change in the frequency of daytime cough. Secondary outcome measures include changes from baseline in health-related quality of life, self-reported cough, and dyspnea.
The trial is currently enrolling participants in England at the Royal Brompton Hospital in London, Manchester University NHS Foundation Trust, and Aintree University Hospital NHS Foundation Trust in Liverpool.
Read more about the epidemiology of IPF
The incidence of IPF is estimated to be 2.91 to 8.65 cases per 100,000 people per year. About 85% of patients with IPF report cough, which can have a considerable negative impact on their quality of life. Other symptoms include exertional dyspnea and finger clubbing.
There are currently no effective treatments that can alleviate cough in patients with IPF.
“This multicenter, randomized trial will assess the effect of opioids on cough counts and cough associated quality of life in IPF subjects,” first author Zhe Wu, MBSS, MRCP, and the coauthors of the study wrote in a report published in Trials. “If proven to be an effective intervention, it represents a readily available treatment for patients.”
The trial is funded by the Moulton Charitable Foundation.
Wu Z, Banya W, Chaudhuri N, et al. PAciFy Cough—a multicentre, double-blind, placebo-controlled, crossover trial of morphine sulphate for the treatment of pulmonary fibrosis cough. Trials. 2022;23(1):184. doi:10.1186/s13063-022-06068-4
Morphine sulfate/placebo for the treatment of pulmonary fibrosis cough (PAciFy Cough). ClinicalTrials.gov. June 12, 2020. Updated March 10, 2021. Accessed March 7, 2022.