Status:
ENROLLING_BY_INVITATION
Determining Airway pH by Compartmental Exhaled Nitric Oxide Levels During Alkaline Buffer Challenge
Lead Sponsor:
Indiana University
Conditions:
Airway Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Airway pH imbalances cause numerous adverse physiological changes within the airways, including hyperreactivity, cough, bronchoconstriction, ciliopathy, decreased response to bronchodilators, bacteria...
Detailed Description
Airway pH imbalances cause numerous adverse physiological changes within the airways, including hyperreactivity, cough, bronchoconstriction, ciliopathy, decreased response to bronchodilators, bacteria...
Eligibility Criteria
Inclusion
- • Study sample will consist of individuals aged 18-60 with a diagnosis of acute or chronic respiratory disorders or normal subjects with no pulmonary disease.
- Healthy subjects may include:
- Adult males or females age ≥ 18 and ≤ 60 years at time of enrollment
- Non-smokers
- Person with no history of asthma, chronic obstructive pulmonary disease (COPD), or other chronic lung disease
- Person with no history of severe allergic/atopic disease requiring immunotherapy or immunomodulators
- Subjects with pulmonary disease may include:
- Person with well-documented disease with objective diagnostics such a lung function or genetic testing.
- Person with FEV1 \> 55% predicted on the day of study procedures.
- Person who is clinically stable with no significant changes in health status within 4 weeks.
Exclusion
- • Subjects that are mechanically ventilated.
- Subjects that are unable or unwilling to cooperate with specimen collection.
- Subjects with diagnosis of any medical condition that in the investigator's opinion would make them unsuitable for study participation.
- Subjects who experienced a pulmonary exacerbation within the 4 weeks prior to visit.
- Subjects requiring continuous oxygen therapy.
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04738422
Start Date
September 11 2020
End Date
July 15 2028
Last Update
December 9 2025
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46219