Observational study of the effect of Pirfenidone on cough in patients with idiopathic pulmonary fibrosis.

Completed

Conditions: Idiopathic pulmonary fibrosis
scarring of the lung
10024967

Registration Number: NL-OMON41593

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

- Diagnosis of IPF according to ATS/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
- TLCOc >= 30% and FVC >= 50%
If a patient is not able to perform a reliable TLCOc measurement because of for instance coughing; TLCOc should be >= 30 % within the past 6 months and FVC should be >= 50% and no emphysema present on CT and no severe pulmonary hypertension on echo.
- 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 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

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To measure with a validated cough recorder the effect of Pirfenidone on cough<br /><br>frequency in patients with IPF </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To measure the effect of Pirfenidone on health status and cough severity<br /><br>using the Leicester Cough Questionnaire and Visual Analogue Score.<br /><br>• To assess the impact of cough on quality of life, anxiety and depression<br /><br>(baseline, week 4 and 12)<br /><br>• To assess the change in cough frequency measured by cough recorder at 4 weeks<br /><br>compared to baseline<br /><br>• To correlate change in cough frequency in relation to lung function<br /><br>• To identify clinical characteristics predictive of cough response </p><br>