Body Composition Related Evaluation of Airway Tone and Hyper-rEactivity Using Oscillometry

NCT07356310 | Recruiting FDA Device

• 1 other identifier: STUDY00011306
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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,

Conditions

Breathing; Lung Function Decreased; Asthma (Diagnosis); Obesity

Outcome Measures

Primary Outcomes (1)

• Oscillometer

  The oscillometer will collect an airway impedance measurement which is made up of multiple variables.

  Single measurement, approximately day 1

Study Arms (1)

Subjects with dyspnea referred for methacholine challenge testing

Subjects with dyspnea being evaluated for asthma who are referred for methacholine challenge testing

Device: Oscillometer

Interventions

Oscillometer DEVICE

The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

Subjects with dyspnea referred for methacholine challenge testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Unable to provide consent or perform oscillometry test

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14620, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Insufficiency; Asthma; Disease; Obesity

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Central Study Contacts

Patrick Donohue, MD

CONTACT

(585) 210-9301; patrick_donohue@urmc.rochester.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 21, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)