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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41593

Enrollment

Registered

2013-11-27

Start date

2013-12-11

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis scarring of the lung

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Opiates, antitussive medication, antihistamines, steroids > equivalent of 10 mg prednisone or NAC within two weeks before study - Change of steroid

Design outcomes

Primary

Measure	Time frame
To measure with a validated cough recorder the effect of Pirfenidone on cough frequency in patients with IPF	—

Secondary

Measure	Time frame
• 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	—

Measure

Time frame

• 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

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Countries

Netherlands

Outcome results