Trial record 3 of 933 for:    cough

The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis (Cough-IPF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Erasmus Medical Center
Sponsor:
Collaborators:
University of Catania
University of Lyon
King's College Hospital NHS Trust
InterMune
Information provided by (Responsible Party):
Marlies Wijsenbeek, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT02009293
First received: December 1, 2013
Last updated: December 8, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Idiopathic Pulmonary Fibrosis
Other: Cough monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Change in cough frequency measured by cough recorder at week 12 compared to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of cough on quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in cough frequency measured by cough recorder at 4 weeks compared to baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in Leicester Cough Questionnaire at week 12 compared to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Visual Analogue Score at week 12 compared to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in cough frequency in relation to FVC [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical characteristics predictive of cough response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Impact of cough on anxiety and depression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in cough frequency in relation to TLCOc [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Cough monitor
questionnaires about cough and quality of life
Other Names:
  • cough monitoring
  • Leicester Cough Monitor

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with IPF about to start on Pirfenidone according to regular practice in the participating University Hospitals

Criteria

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) ≥ 35% 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009293

Contacts
Contact: M. S. Wijsenbeek, MD, PhD m.wijsenbeek-lourens@erasmusmc.nl
Contact: A. Geel a.geel@erasmusmc.nl

Locations
France
University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel Not yet recruiting
Lyon, France
Contact: V Cottin, Prof.    +33472357652    vincent.cottin@chu-lyon.fr   
Italy
Regional Centre for Rare Lung Disease University of Catania. Recruiting
Catania, Italy
Contact: C Vancheri    +3401830553    vancheri@unict.it   
Netherlands
Erasmus MC Rotterdam, Dep. of Pulmonology Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: M Wijsenbeek, MD PhD    +31-10-7030033    m.wijsenbeek-lourens@erasmusmc.nl   
Contact: A. Geel       research.longziekten@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center
University of Catania
University of Lyon
King's College Hospital NHS Trust
InterMune
Investigators
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
  More Information

No publications provided

Responsible Party: Marlies Wijsenbeek, MD PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02009293     History of Changes
Other Study ID Numbers: NL44729.078.13
Study First Received: December 1, 2013
Last Updated: December 8, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
idiopathic pulmonary fibrosis
cough
quality of life

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014