The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT02009293
Last Updated: 2016-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
43 participants
OBSERVATIONAL
2013-12-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cough IPF
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.
Cough monitor
questionnaires about cough and quality of life
Interventions
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Cough monitor
questionnaires about cough and quality of life
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
85 Years
ALL
No
Sponsors
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University of Catania
OTHER
University of Lyon
OTHER
King's College Hospital NHS Trust
OTHER
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Marlies Wijsenbeek
MD PhD
Principal Investigators
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M. S. Wijsenbeek, Dr.
Role: STUDY_CHAIR
Erasmus Medical Centre Rotterdam, The Netherlands
C. Vancheri, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Catania, Italy
V. Cottin, Prof.
Role: PRINCIPAL_INVESTIGATOR
Louis Pradel hospital, Lyon, France
S Birring, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Respiratory Medicine,King's College Hospital.Denmark Hill, London
A Russell
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton & Harefield NHS Foundation Trust
E Renzoni, Dr.
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton & Harefield NHS Foundation Trust
Locations
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University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel
Lyon, , France
Regional Centre for Rare Lung Disease University of Catania.
Catania, , Italy
Erasmus MC Rotterdam, Dep. of Pulmonology
Rotterdam, , Netherlands
Countries
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Other Identifiers
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NL44729.078.13
Identifier Type: -
Identifier Source: org_study_id