Observational study: effect of Pirfenidone on cough in IPF patients
Research type
Research Study
Full title
Observational study of the effect of Pirfenidone on cough in patients with idiopathic pulmonary fibrosis
IRAS ID
162466
Contact name
Anne-Marie Russell
Contact email
Sponsor organisation
Erasmus MC
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Observational study of the effect of Pirfenidone on cough in patients diagnosed with idiopathic pulmonary fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF) is a fibrotic lung disease of unknown cause that can progress very rapidly. Patients diagnosed with IPF have a shortened life expectancy. There are no treatments available to cure this condition but in 2011 Pirfenidone, was approved initially in Europe and then in the UK. This medication slows down the progression of IPF, thereby increasing life expectancy. In patients with IPF, the most common symptoms are cough and breathlessness. Cough can be distressing and may impact negatively upon quality of life. We know from previous studies that cough independently predicts progression of IPF and death. Recent preliminary data suggests that Pirfenidone appears to improve the symptom of cough.
In this study we want to measure the effect that Pirfenidone may have on cough in patients diagnosed with IPF. This is an international multi-centre study. Men and women aged 40-85 who have been diagnosed with IPF and have been identified as meeting the criteria to start on Pirfenidone (as part of clinical practice) will be invited to participate.
Participants who agree to take part will be given a Leicester Cough Monitor (LCM). This is a validated cough monitoring system for mobile use. A 24-hour cough frequency will be recorded at entry to the study; again at 4 weeks and then at 12 weeks during treatment with Pirfenidone. On the days of cough recording, patients will be asked to fill in questionnaires related to cough and to quality of life.
Recording the cough sounds and filling in questionnaires is not expected to change the course of participant’s disease or cause side effects. It will help us to better understand the experience of cough in patients taking Pirfenidone.REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/0957
Date of REC Opinion
16 Jul 2015
REC opinion
Further Information Favourable Opinion