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

• Status: Active, not recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University
• Treatments: Glycine

Criteria

Inclusion Criteria:

• • 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:

1. Adult males or females age ≥ 18 and ≤ 60 years at time of enrollment

2. Non-smokers

3. Person with no history of asthma, chronic obstructive pulmonary disease (COPD), or other chronic lung disease

4. Person with no history of severe allergic/atopic disease requiring immunotherapy or immunomodulators

Subjects with pulmonary disease may include:

1. Person with well-documented disease with objective diagnostics such a lung function or genetic testing.

2. Person with FEV1 > 55% predicted on the day of study procedures.

3. Person who is clinically stable with no significant changes in health status within 4 weeks.

Exclusion Criteria:

• • 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.