Optimization of Exhaled Biomarker Collection and Analysis (EBC)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy; Respiratory Disease
• Intervention / Treatment: Other: Breath collection

Detailed Description

Exhaled breath has three fractions - gaseous breath, volatile breath, and breath condensate. Biomarkers have been identified in each of these fractions and non-invasive collection methods have been developed. Exhaled breath can be safely and easily performed in all patient populations, including neonatal children and the elderly. We have shown that relative to normal controls, condensed exhalates obtained from asthmatic subjects reproducibly contain elevated concentrations of oxides of nitrogen and are more acidic (having hydrogen ion concentrations two to three log orders higher). We wish to extend these studies across all breath fractions and other lung diseases and respiratory processes including viral upper respiratory tract infections, cystic fibrosis, pneumonia, pulmonary hypertension, bronchiolitis obliterans, chronic obstructive pulmonary disease, tracheostomized patients and cigarette smokers. Through this study extension, we will obtain pilot data/preliminary information about the potential utility of this new technique to non-invasively evaluate disease status in various respiratory diseases. We also wish to obtain data regarding specificity by evaluating the exhaled breath obtained from patients with non-respiratory illnesses, such as, but not limited to diabetes, gastroenteritis, and various inflammatory disorders. We think it is likely that the exhaled biomarkers reflect underlying airway inflammation and infection.

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.

Subjects may be asked to provide several specimens during the course of their inpatient stay or clinic visit to obtain longitudinal data.

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.

Exhaled breath collection technique is completely comfortable, causing neither discomfort nor fatigue.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine - Wells Center for Pediatric Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 110 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single Visit breath collection; 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; Exhaled breath will be passively collected from subjects during quiet oral breathing through a simple mouthpiece or mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2020
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: 1910580775

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No