Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
Observational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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