In this study we want to objectively measure the effect of Pirfenidone on cough in patients with IPF.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To measure with a validated cough recorder the effect of Pirfenidone on cough
frequency in patients with IPF
Secondary outcome
• To measure the effect of Pirfenidone on health status and cough severity
using the Leicester Cough Questionnaire and Visual Analogue Score.
• To assess the impact of cough on quality of life, anxiety and depression
(baseline, week 4 and 12)
• To assess the change in cough frequency measured by cough recorder at 4 weeks
compared to baseline
• To correlate change in cough frequency in relation to lung function
• To identify clinical characteristics predictive of cough response
Background summary
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.
Study objective
In this study we want to objectively measure the effect of Pirfenidone on cough
in patients with IPF.
Study design
This is a prospective, observational, international multicenter study.
Study burden and risks
Patients with IPF participating in this study will not have personal benefit
from participating in this study. The burden is low, patients will be asked to
carry a small ambulatory cough monitor for three times 24 hours and to fill in
questionnaires three times at there regular outpatient visits (duration 3 X 30
minutes).There is no risk in participation of the study. Recording cough sounds
and filling in questionnaires is not expected to change the course of their
disease or cause side effects. Treatment decisions will be at the discretion of
the treating physician and not be influenced by the study. The outcome of the
study may improve future care of patients with IPF.
Dr.molenwaterplein 50
Rotterdam 3015 GD
NL
Dr.molenwaterplein 50
Rotterdam 3015 GD
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44729.078.13 |