Determining Airway pH by Compartmental Exhaled Nitric Oxide Levels During Alkaline Buffer Challenge
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT04738422
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
- Airway Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Alkaline glycine — DRUGSubjects will inhale alkaline glycine via nebulizer. Alkaline glycine is an alkaline medication designed for medication.
Study Details
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.
Key Dates
- Start date
- Sep 11, 2020
- Status verified
- Dec 2025
- Primary completion
- Jul 15, 2028
- Completion
- Jul 15, 2028
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Alkaline glycine InhalationSubjects inhale alkaline glycine
Primary Outcome Measure
Compartmental FeNO [ Time Frame: Study is a single visit, lasting less than two hours ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46219 | - |
Find similar trials in Indianapolis, IN
Related Studies
- Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN)Enrolling By Invitation · NYU Langone Health · New York, New York
- Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)Not Yet Recruiting · University of Southern California · Los Angeles, California