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

NCT04738422 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: 2003838272
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Compartmental FeNO

  Measuring compartmental FeNO before inhaled alkaline glycine and after inhaled alkaline glycine

  Study is a single visit, lasting less than two hours

• Calculated compartmental airway pH

  Calculating compartmental FeNO before inhaled alkaline glycine and after inhaled alkaline glycine

  Study is a single visit, lasting less than two hours

• Exhaled Breath Condensate (EBC) pH

  Measuring the pH of EBC before and after inhaled alkaline glycine

  Study is a single visit, lasting less than two hours

Study Arms (1)

Alkaline glycine Inhalation

EXPERIMENTAL

Subjects inhale alkaline glycine

Drug: Alkaline glycine

Interventions

Alkaline glycine DRUG

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

Also known as: Optate

Alkaline glycine Inhalation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• 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.

You may not qualify 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46219, United States

Location

MeSH Terms

Interventions

Optate

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: September 11, 2020
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (1)