What this study is
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.
What's being tested
- Alkaline glycine
Intervention · DRUG
Subjects will inhale alkaline glycine via nebulizer. Alkaline glycine is an alkaline medication designed for medication.
Study details
- Sponsor
- Indiana University
- Conditions
- Airway Disease
- Enrolling
- 150 people
- Starts
- 2020-09-11
- Est. completion
- 2028-07-15
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers AcceptedAll participants
You may qualify if
- 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.
You can't join if
- 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.
Healthy subjects may
You may qualify if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openIndiana University School of Medicine
Indianapolis, Indiana, United States
Study team
Sponsor
Indiana University
Study ID 2003838272
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.