Clinical Trial

Determining Airway pH by Compartmental Exhaled Nitric Oxide Levels During Alkaline Buffer Challenge

Enrolling by Invitation Phase 2
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Summary
Airway pH imbalances cause numerous adverse physiological changes within the airways, including hyperreactivity, cough, bronchoconstriction, ciliopathy, decreased response to bronchodilators, bacterial growth, nitrosative/oxidative stress, neutrophilic/eosinophilic inflammation, and cell death. Airway pH is known to be low (acidic) in chronic and acute pulmonary diseases. The gold standard approach to measuring airway pH is to bronchscopically obtain epithelial cell lining fluid using protected brush sampling. The expense and invasive nature of this approach is a barrier to fully characterizing the role of airway pH in the health and disease. In this study, we will evaluate non-invasive clinical methods that can be done using equipment standard in clinical pulmonary function laboratories for measuring airway pH.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-02-01; most recent amendment 2025-12-02.
Status change: Recruiting → Enrolling by Invitation 2024-02-05
Status change: Active, Not Recruiting → Recruiting 2022-05-24
Status change: Recruiting → Active, Not Recruiting 2021-08-24
Trial Details
NCT Number NCT04738422
Lead Sponsor Indiana University
Conditions Airway Disease
Enrollment 150 participants
Start Date 2020-09-11
Primary Completion 2028-07-15 (estimated)
Study Completion 2028-07-15 (estimated)
Updated on ClinicalTrials.gov 2025-12-09