The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis (Cough-IPF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02009293|
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : December 23, 2016
|Condition or disease||Intervention/treatment|
|Idiopathic Pulmonary Fibrosis||Other: Cough monitor|
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 Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Observational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis|
|Study Start Date :||December 2013|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
U.S. FDA Resources
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.
Other: Cough monitor
questionnaires about cough and quality of life
- Change in cough frequency measured by cough recorder at week 12 compared to baseline [ Time Frame: 12 weeks ]
- 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 ]
- Change in Leicester Cough Questionnaire at week 12 compared to baseline [ Time Frame: 12 weeks ]
- Change in Visual Analogue Score at week 12 compared to baseline [ Time Frame: 12 weeks ]
- Change in cough frequency in relation to FVC [ Time Frame: 12 weeks ]
- Clinical characteristics predictive of cough response [ Time Frame: 12 weeks ]
- Impact of cough on anxiety and depression [ Time Frame: 12 weeks ]
- Change in cough frequency in relation to TLCOc [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009293
|University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel|
|Regional Centre for Rare Lung Disease University of Catania.|
|Erasmus MC Rotterdam, Dep. of Pulmonology|
|Rotterdam, Netherlands, 3015 CE|
|Study Chair:||M. S. Wijsenbeek, Dr.||Erasmus Medical Centre Rotterdam, The Netherlands|
|Principal Investigator:||C. Vancheri, Prof.||University of Catania, Italy|
|Principal Investigator:||V. Cottin, Prof.||Louis Pradel hospital, Lyon, France|
|Principal Investigator:||S Birring, Dr.||Department of Respiratory Medicine,King's College Hospital.Denmark Hill, London|
|Principal Investigator:||A Russell||Royal Brompton & Harefield NHS Foundation Trust|
|Principal Investigator:||E Renzoni, Dr.||Royal Brompton & Harefield NHS Foundation Trust|