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

StatusEnrolling by Invitation
PhasePhase 2
Started2020-09-11
View on ClinicalTrials.gov ↗

Amendment history

2025-12-02
minor
Study Identification, Study Status, Oversight v9
Primary completion date2025-11-30→2028-07-15
Completion date2025-11-30→2028-07-15
Study titlerevised
Determining Airway PHpH by Compartmental Exhaled Nitric Oxide Levels During Alkaline Buffer Challenge
2024-09-27
minor
Study Identification, Study Status, Oversight v8
Primary completion date2024-11-30→2025-11-30
Completion date2024-11-30→2025-11-30
Study titlerevised
Determining Airway pHPH by Compartmental Exhaled Nitric Oxide Levels During Alkaline Buffer Challenge
2024-04-02
minor
Study Status, Study Design v7
Enrollment target500→150
2024-02-05
notable
Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v6
Trial statusRecruiting→Enrolling by Invitation
Study sitesdetails revised at 1 of 1 site
2023-08-23
minor
Study Status v5
Primary completion date2023-11-30→2024-11-30
Completion date2023-11-30→2024-11-30
Show 4 earlier versions
2023-07-24
minor
Study Status v4
Re-verified, no change to tracked fields
2022-05-24
notable
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusActive, Not Recruiting→Recruiting
Completion date2023-12-31→2023-11-30
Study sitesdetails revised at 1 of 1 site
2021-11-11
minor
Study Status v2
Re-verified, no change to tracked fields
2021-08-24
notable
Recruiting→Active, Not Recruiting Study Status, Oversight, Study Description, Contacts/Locations v1
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2023-12-31→2023-11-30
Completion date2025-12-31→2023-12-31
Study description+167 characters
[...] role of airway pH in the health and disease. In this study, wethe investigator will evaluate non-invasive clinical methods that can be don [...] al pulmonary function laboratories for measuring airway pH. OurThe groupstudy team has previously demonstrated that exhaled breath condensate [...] ommon method and validated method for estimating airway pH, wethe believeinvestigators believes that the change in FeNO50 is the most sensitive test for general airway pH. Specifically, ourthis proposed test makes use of the facts that the pH of nitrite [...] st for airway pH. Using the Henderson-Hasselbalch equation, wethe i [...] [...]
Study sitesdetails revised at 1 of 1 site
2021-02-01
minor
Original filing
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.
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