NCT02009293

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

3 years

First QC Date

December 1, 2013

Last Update Submit

December 21, 2016

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

idiopathic pulmonary fibrosiscoughquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in cough frequency measured by cough recorder at week 12 compared to baseline

    12 weeks

Secondary Outcomes (2)

  • 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

Other Outcomes (6)

  • Change in Leicester Cough Questionnaire at week 12 compared to baseline

    12 weeks

  • Change in Visual Analogue Score at week 12 compared to baseline

    12 weeks

  • Change in cough frequency in relation to FVC

    12 weeks

  • +3 more other outcomes

Study Arms (1)

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

Interventions

Cough monitorOTHER

questionnaires about cough and quality of life

Also known as: cough monitoring, Leicester Cough Monitor
Cough IPF

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel

Lyon, France

Location

Regional Centre for Rare Lung Disease University of Catania.

Catania, Italy

Location

Erasmus MC Rotterdam, Dep. of Pulmonology

Rotterdam, 3015 CE, Netherlands

Location

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisCough

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • M. S. Wijsenbeek, Dr.

    Erasmus Medical Centre Rotterdam, The Netherlands

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 1, 2013

First Posted

December 11, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 23, 2016

Record last verified: 2016-12

Locations

IT(1)NL(1)FR(1)