Optimization of Exhaled Biomarker Collection and Analysis

NCT05322785 | Enrolling By Invitation

• 1 other identifier: 1910580775
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory study designed to optimize, standardize, and validate novel breath biomarkers; there are no objective endpoints. The goal of this study is to generate pilot data to be used to generate hypothesis-driven studies.

Conditions

Respiratory Disease; Healthy

Outcome Measures

Primary Outcomes (1)

• Breath amount, pH, components

  Breath collected will be measured for total volume of condensation collected, pH from the pH scale and other components of airway factors

  During the exhaled breath collection procedure, not to exceed 30 minutes

Study Arms (1)

Single Visit breath collection

OTHER

Following informed consent, exhaled breath will be passively collected from subjects during quiet oral breathing through a simple mouthpiece or mask. Exhaled breath will be diverted into a collection device, which may include a bag, tube, or other device with minimal resistance. The collection process, including completing forms, will not exceed 30 minutes. At no time will the patients be breathing anything other than ambient air with or without oxygen enrichment as clinically indicated. Inhaled air will not be manipulated.

Other: Breath collection

Interventions

Breath collection OTHER

Exhaled breath will be passively collected from subjects during quiet oral breathing through a simple mouthpiece or mask

Single Visit breath collection

Eligibility Criteria

• Age: 4 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Study sample will consist of individuals aged 4-110 with a diagnosis of acute or chronic respiratory disorders, or metabolic or systemic conditions involving diffuse inflammation, or normal subjects with no pulmonary disease.

You may not qualify if:

• Subjects that are unable or unwilling to cooperate with specimen collection.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine - Wells Center for Pediatric Research

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

• Davis MD, Fowler SJ, Montpetit AJ. Exhaled breath testing - A tool for the clinician and researcher. Paediatr Respir Rev. 2019 Feb;29:37-41. doi: 10.1016/j.prrv.2018.05.002. Epub 2018 May 17.

  PMID: 29921519 BACKGROUND

• Davis MD, Montpetit AJ. Exhaled Breath Condensate: An Update. Immunol Allergy Clin North Am. 2018 Nov;38(4):667-678. doi: 10.1016/j.iac.2018.06.002. Epub 2018 Sep 21.

  PMID: 30342587 BACKGROUND

• Vaughan J, Ngamtrakulpanit L, Pajewski TN, Turner R, Nguyen TA, Smith A, Urban P, Hom S, Gaston B, Hunt J. Exhaled breath condensate pH is a robust and reproducible assay of airway acidity. Eur Respir J. 2003 Dec;22(6):889-94. doi: 10.1183/09031936.03.00038803.

  PMID: 14680074 BACKGROUND

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: Study sample will consist of individuals aged 4-110 with a diagnosis of acute or chronic respiratory disorders, or metabolic or systemic conditions involving diffuse inflammation, or normal subjects with no pulmonary disease.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 12, 2022
• Study Start: February 2, 2020
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)