Body Composition Related Evaluation of Airway Tone and Hyper-rEactivity Using Oscillometry (BREATH-OSC)

This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on methacholine challenge testing and whether these findings are associated with body habitus,

Study Overview

• Status: Recruiting
• Conditions: Obesity; Breathing; Lung Function Decreased; Asthma (Diagnosis)
• Intervention / Treatment: Device: Oscillometer

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Patrick Donohue, MD; Phone Number: (585) 210-9301; Email: patrick_donohue@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Recruiting
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to one hundred (100) human subjects will be recruited from the following University of Rochester locations: Mary Parkes Center for Asthma, Allergy, and Pulmonary Care, the Pulmonary Clinic at Strong Memorial Hospital, and The Pulmonary Clinic at Highland Hospital.

Description

Inclusion Criteria:

• Willingness to perform breathing test
• Must be able to speak and understand English
• Referred for Methacholine Challenge Test

Exclusion Criteria:

• Unable to provide consent or perform oscillometry test

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with dyspnea referred for methacholine challenge testing; Subjects with dyspnea being evaluated for asthma who are referred for methacholine challenge testing	Device: Oscillometer; The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oscillometer	The oscillometer will collect an airway impedance measurement which is made up of multiple variables.	Single measurement, approximately day 1

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Asthma; Respiratory Insufficiency; Disease; Respiratory Aspiration
• Other Study ID Numbers: STUDY00011306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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