BreathingBREATH-OSCNCT07356310
Body Composition Related Evaluation of Airway Tone and Hyper-rEactivity Using Oscillometry
An observational study of Breathing and Lung Function Decreased, run by University of Rochester at 1 site in United States.
Trial 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, Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing, Lung Function Decreased, Asthma (Diagnosis)
- What is being tested?
- Oscillometer
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Willingness to perform breathing test
- Must be able to speak and understand English
- Referred for Methacholine Challenge Test
Who cannot join
- Unable to provide consent or perform oscillometry test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14620
About this study
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
- Being tested
- Oscillometer
- Medical subject headings
- Respiratory Aspiration, Respiratory Insufficiency, Asthma, Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OscillometerDevice
The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
| Study group | Role | What they receive |
|---|---|---|
| Subjects with dyspnea referred for methacholine challenge testing | Subjects with dyspnea being evaluated for asthma who are referred for methacholine challenge testing Receives: Device: Oscillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oscillometer
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
Measured: Single measurement, approximately day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start17 Feb 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreathingStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Donohue, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356310
- Sponsor's protocol ID
- STUDY00011306
- Acronym
- BREATH-OSC
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Related Evaluation of Airway Tone and Hyper-rEactivity Using Oscillometry
- ClinicalTrials.gov ID
- NCT07356310
- Acronym / sponsor ID
- BREATH-OSC / STUDY00011306
- Conditions
- Breathing, Lung Function Decreased, Asthma (Diagnosis), Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with dyspnea referred for methacholine challenge testing | – | Device: OscillometerSubjects with dyspnea being evaluated for asthma who are referred for methacholine challenge testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Willingness to perform breathing test
- Must be able to speak and understand English
- Referred for Methacholine Challenge Test
Key exclusion criteria (1 listed)
- Unable to provide consent or perform oscillometry test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OscillometerThe tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). | Device | Subjects with dyspnea referred for methacholine challenge testing |
Primary outcome
Oscillometer
Time frame: Single measurement, approximately day 1
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breathing and Lung Function Decreased, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Donohue, MD ((585) 210-9301, patrick_donohue@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oscillometer (time frame: Single measurement, approximately day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.