Idiopathic Pulmonary Fibrosis | The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Idiopathic Pulmonary Fibrosis
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Cough monitorquestionnaires about cough and quality of life
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Cough IPFMale 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.
Start Date: December 2013
Completed Date: December 2016
Primary Outcome: Change in cough frequency measured by cough recorder at week 12 compared to baseline
Secondary Outcome: Impact of cough on quality of life
Study sponsors, principal investigator, and references
Principal Investigator: M. S. Wijsenbeek, Dr.
Lead Sponsor: Erasmus Medical Center
Collaborator: University of Catania