Clinical Trial: The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Observational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis
Brief Summary: In this study we evaluate the effect of Pirfenidone on cough and quality of life in patients with idiopathic pulmonary fibrosis (IPF) that are treated with Pirfenidone in daily practice. The hypothesis is that Pirfenidone will decrease cough and increase quality of life.
Detailed Summary:
Rationale: Idiopathic Pulmonary Fibrosis (IPF) is a progressive fibrotic lung disease of unknown cause with a median survival of 3-5 years. No curative treatment exists, though in 2011 Pirfenidone was approved for the treatment of IPF as it appeared to slow down the decline in lung function. In patients with IPF, the most common symptoms are cough and breathlessness. Cough is not only a major distressing and disabling symptom but also an independent predictor of disease progression and death in IPF. Recent preliminary data suggest a possible effect of Pirfenidone on cough.
Objective: In this study we want to objectively measure the effect of Pirfenidone on cough in patients with IPF that are treated with Pirfenidone in daily practice .
Study design: This is a prospective, observational, international multicenter study.
Intervention: Objective 24-hour cough frequency will be recorded using the Leicester Cough Monitor (LCM), a validated ambulatory cough monitoring system, prior to starting with Pirfenidone treatment. The cough recording will be repeated at 4 weeks and at 12 weeks during treatment with Pirfenidone. At the days of cough recording, patients will be asked to fill in questionnaires related to cough and to quality of life. Patient will be treated according to normal clinical practice at their Physician's discretion.
Main study parameters/endpoints: The primary endpoint is change in cough frequency measured by the Leicester cough monitor at week 12 compared to baseline. Secondary endpoints look at the relationships between cough, change in cough, quality of life and clinical parameters.
Sponsor: Erasmus Medical Center
Current Primary Outcome: Change in cough frequency measured by cough recorder at week 12 compared to baseline [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Impact of cough on quality of life [ Time Frame: 12 weeks ]
- Change in cough frequency measured by cough recorder at 4 weeks compared to baseline [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Erasmus Medical Center
Dates:
Date Received: December 1, 2013
Date Started: December 2013
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2016
