Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02009293
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT02009293
Study Brief:
Protocol Section:
NCT02009293