The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— Cough-IPF  

Official title:

Observational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009293
• Other study ID #: NL44729.078.13
• Status: Completed
• Phase: N/A
• First received: December 1, 2013
• Last updated: December 21, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• Cough monitor
questionnaires about cough and quality of life

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Erasmus Medical Center	King's College Hospital NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, University of Catania, University of Lyon

Countries where clinical trial is conducted

France,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Leicester Cough Questionnaire at week 12 compared to baseline		12 weeks	No
Other	Change in Visual Analogue Score at week 12 compared to baseline		12 weeks	No
Other	Change in cough frequency in relation to FVC		12 weeks	No
Other	Clinical characteristics predictive of cough response		12 weeks	No
Other	Impact of cough on anxiety and depression		12 weeks	No
Other	Change in cough frequency in relation to TLCOc		12 weeks	No
Primary	Change in cough frequency measured by cough recorder at week 12 compared to baseline		12 weeks	No
Secondary	Impact of cough on quality of life		12 weeks	No
Secondary	Change in cough frequency measured by cough recorder at 4 weeks compared to baseline		4 weeks	No