The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Other: Cough monitor

• Registration Number: NCT02009293
• Lead Sponsor: Erasmus Medical Center

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 Description

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-01
• Study First Submitted QC: 2013-12-08
• Study First Posted: 2013-12-11
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Diagnosis of IPF according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria (5), definite and probable patients will be eligible
• Written informed consent
• Daily cough related to IPF (exclusion of other causes) present > 8 weeks
• cough score on visual analogue scale of ≥ 40 mm.
• Carbon monoxide transfer capacity corrected for hemoglobin (TLCOc) ≥ 30% and Forced Vital Capacity (FVC) ≥ 50%
• Pirfenidone therapy about to be initiated
• if a history positive for Gastro Esophageal Reflux (GER), using proton pump inhibitor (PPI) > 4 weeks

Exclusion Criteria

• Opiates, antitussive medication, antihistamines, steroids > equivalent of 10 mg prednisone or N-acetylcysteine (NAC) within two weeks before study
• Change of steroid < 10 mg, inhalation steroids within 2 weeks of the study - History of bronchial hyper responsiveness or asthma or relevant airway obstruction (FEV1/FVC < 0.7)
• within 6 weeks of the start signs of respiratory tract infection, change of sputum production and fever.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cough IPF	Cough monitor	Male and female with idiopathic pulmonary fibrosis and cough and about to start on Pirfenidone according to regular practice will be asked to wear a cough monitor 24 hours before starting Pirfenidone and twice 24 hours while using Pirfenidone. Patients will also be asked to fill in questionnaires about quality of life and cough.

Primary Outcome Measures

Name	Time	Method
Change in cough frequency measured by cough recorder at week 12 compared to baseline	12 weeks

Secondary Outcome Measures

Name	Time	Method
Impact of cough on quality of life	12 weeks
Change in cough frequency measured by cough recorder at 4 weeks compared to baseline	4 weeks

Trial Locations

Locations (3)

Regional Centre for Rare Lung Disease University of Catania.; 🇮🇹 Catania, Italy

Erasmus MC Rotterdam, Dep. of Pulmonology; 🇳🇱 Rotterdam, Netherlands

University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel; 🇫🇷 Lyon, France