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

December 21, 2016 updated by: Marlies Wijsenbeek, Erasmus Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel
  • Italy
      • Catania, Italy
        • Regional Centre for Rare Lung Disease University of Catania.
  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus MC Rotterdam, Dep. of Pulmonology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in cough frequency measured by cough recorder at week 12 compared to baseline
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Impact of cough on quality of life
Time Frame: 12 weeks
12 weeks
Change in cough frequency measured by cough recorder at 4 weeks compared to baseline
Time Frame: 4 weeks
4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in Leicester Cough Questionnaire at week 12 compared to baseline
Time Frame: 12 weeks
12 weeks
Change in Visual Analogue Score at week 12 compared to baseline
Time Frame: 12 weeks
12 weeks
Change in cough frequency in relation to FVC
Time Frame: 12 weeks
12 weeks
Clinical characteristics predictive of cough response
Time Frame: 12 weeks
12 weeks
Impact of cough on anxiety and depression
Time Frame: 12 weeks
12 weeks
Change in cough frequency in relation to TLCOc
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College Hospital NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
University of Catania
University of Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL44729.078.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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