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