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

NCT04738422 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-09

No results posted yet for this study

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.

Conditions

  • Airway Disease

Interventions

DRUG

Alkaline glycine

Subjects will inhale alkaline glycine via nebulizer. Alkaline glycine is an alkaline medication designed for medication.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2028-07-15
Completion
2028-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738422 on ClinicalTrials.gov