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:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT05086432
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed
* Age \>18 years
* A clinical diagnosis of ILD with accepted specific diagnoses including:
* Idiopathic pulmonary fibrosis (IPF)
* Chronic hypersensitivity pneumonitis associated ILD (CHP-ILD)
* Connective tissue disease associated ILD (CTD-ILD)
* Pneumoconiosis
* Daily Cough for at least 8 weeks
* Able to produce an adequate sample with sputum induction
Exclusion Criteria:
* Patients with a diagnosis of systemic sclerosis associated ILD (SSc-ILD) or sarcoidosis
* Cause of cough attributed to a known etiology (ex. ACE-inhibitor, uncontrolled gastroesophageal reflux or upper airway cough syndrome, acute viral illness)
* Current use of inhaled corticosteroids
* Current use of systemic corticosteroids (prednisone equivalent \> 20mg/day)
* Current use of chronic antibiotics
* Airflow obstruction (ie. pre-bronchodilator FEV1/FVC ratio \< 0.7)
* History of physician-diagnosed asthma
* History of emphysema
* A history of cholestatic jaundice or hepatic dysfunction associated with prior use of azithromycin
* Moderate to severe hepatic dysfunction with a Child Pugh score \>10
* Known allergy or hypersensitivity to inhaled corticosteroids or macrolide antibiotics
* Corrected QT-interval (QTc) on screening electrocardiogram (ECG) of \> 450ms
* An established history of untreated atypical mycobacterial infection
* A history of hearing impairment, tinnitus, or vertigo
* Medication use likely to suppress cough (ex: morphine, gabapentin, amitriptyline)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05086432
Study Brief:
Protocol Section:
NCT05086432