AsthmaNCT07071194
Asthma and Osteopathic Manipulative Technique
A study testing OMT and Light touch in people with Asthma, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Asthma is a common respiratory condition that can be difficult to control despite the use of medications such as inhalers, oral steroids or even injectable medications. Osteopathic Manipulative Treatment (OMT) is a hands-on technique used to improve the chest structure and function and may help in improving breathing. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- OMT and Light touch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients in Allergy and Immunology Associates clinic diagnosed with asthma ages 18-60 years old with an elevated FENO
Who cannot join
- Use of oral steroids within the last 4 weeks
- Use of biologic medications
- Diagnosis of pregnancy, osteoporosis, congestive heart failure, renal failure, cirrhosis, or cancer
- Inability to lay recumbent
Trial locations and contacts
1 site in 1 country.
United States1 site
Allergy Immunology Associates
Mayfield Heights, Ohio, 44124
About this study
Official title: The Effect of Osteopathic Manipulative Treatment on Respiratory Function in Patients With Asthma
Asthma is a common respiratory condition that can be difficult to control despite the use of medications such as inhalers, oral steroids or even injectable medications. Osteopathic Manipulative Treatment (OMT) is a hands-on technique used to improve the chest structure and function and may help in improving breathing. Previous research showed that OMT in asthma patients, can improve the movement of the ribs and improve the "peak flow" which is the maximum rate at which a person can exhale air after taking a deep breath. However, no studies have evaluated the impact of OMT on lung inflammation.
This single-site research study at University Hospitals aims to evaluate whether Osteopathic Manipulative Treatment (OMT) can reduce lung inflammation and improve breathing and lung function in adult patients with asthma. The lung function will be evaluated by Spirometry which is a test that measures how much air you can breathe in and out of your lungs, as well as how quickly and easily you can exhale air. The lung inflammation will be measured using a device that can detect how much you are breathing out Nitric Oxide which is a gas produced by inflamed cells in the lungs, this test is called: Fractional exhaled Nitric Oxide or FeNO. Approximately 100 participants will be enrolled.
- Conditions
- Asthma
- Being tested
- OMT, Light touch
- Keywords
- Osteopathic Manipulative Treatment, Lung inflammation, Improved breathing
- Medical subject headings
- Asthma, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMTProcedure or surgery
Patients in the treatment group will undergo OMT using sub-occipital release, rib raising, doming the diaphragm, thoracic inlet release and myofascial techniques.
Light touchOther
Patients in the control group will undergo light touch in similar locations to OMT.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group using OMT | Experimental | Patients in the treatment group will undergo OMT using sub-occipital release, rib raising, doming the diaphragm, thoracic inlet release and myofascial techniques. Receives: Procedure: OMT |
| Control group | Active comparator | Patients in the control group will undergo light touch in similar locations to above performed OMT. Receives: Other: Light touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fractionated Exhaled Nitric Oxide (FeNO) values as measured by NIOX FeNO device
Measured: Baseline, after OMT treatment (up to 30 minutes), day 10
Change in Peak Expiratory Flow values as measured by EasyOne Air Spirometer device
Measured: Baseline, after OMT treatment (up to 30 minutes), day 10
Secondary outcomes (3)
Change in Ease of breathing as measured by Post-OMT Questionnaire
The post_OMT Questionnaire scores ease of breathing on a Likert scale of 1-0 with 1 being difficult to breathe and 10 being easy to breath
Measured: Baseline and day 10
Change in Rib Cage mobility as measured by Post-OMT Questionnaire
The post_OMT Questionnaire scores Rib Cage mobility on a Likert scale of 1-0 with 1 being stiff and 10 being mobile
Measured: Baseline and day 10
Change in chest tightness as measured by Post-OMT Questionnaire
The post_OMT Questionnaire scores chest tightness on a Likert scale of 1-0 with 1 being tight and 10 being loose
Measured: Baseline and day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Why it stopped: No plan to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Wasserbauer-Kingston, DO, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071194
- Sponsor's protocol ID
- STUDY20250241
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Manipulative Treatment on Respiratory Function in Patients With Asthma
- ClinicalTrials.gov ID
- NCT07071194
- Acronym / sponsor ID
- STUDY20250241
- Conditions
- Asthma
- Keywords
- Osteopathic Manipulative Treatment, Lung inflammation, Improved breathing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No plan to continue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 17 Jul 2025 (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.
Asthma is a common respiratory condition that can be difficult to control despite the use of medications such as inhalers, oral steroids or even injectable medications. Osteopathic Manipulative Treatment (OMT) is a hands-on technique used to improve the chest structure and function and may help in improving breathing. Previous research showed that OMT in asthma patients, can improve the movement of the ribs and improve the "peak flow" which is the maximum rate at which a person can exhale air after taking a deep breath. However, no studies have evaluated the impact of OMT on lung inflammation.
This single-site research study at University Hospitals aims to evaluate whether Osteopathic Manipulative Treatment (OMT) can reduce lung inflammation and improve breathing and lung function in adult patients with asthma. The lung function will be evaluated by Spirometry which is a test that measures how much air you can breathe in and out of your lungs, as well as how quickly and easily you can exhale air. The lung inflammation will be measured using a device that can detect how much you are breathing out Nitric Oxide which is a gas produced by inflamed cells in the lungs, this test is called: Fractional exhaled Nitric Oxide or FeNO. Approximately 100 participants will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group using OMT | Experimental | Procedure: OMTPatients in the treatment group will undergo OMT using sub-occipital release, rib raising, doming the diaphragm, thoracic inlet release and myofascial techniques. |
| Control group | Active comparator | Other: Light touchPatients in the control group will undergo light touch in similar locations to above performed OMT. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female patients in Allergy and Immunology Associates clinic diagnosed with asthma ages 18-60 years old with an elevated FENO
Key exclusion criteria (4 listed)
- Use of oral steroids within the last 4 weeks
- Use of biologic medications
- Diagnosis of pregnancy, osteoporosis, congestive heart failure, renal failure, cirrhosis, or cancer
- Inability to lay recumbent
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 |
|---|---|---|
| OMTPatients in the treatment group will undergo OMT using sub-occipital release, rib raising, doming the diaphragm, thoracic inlet release and myofascial techniques. | Procedure or surgery | Treatment group using OMT |
| Light touchPatients in the control group will undergo light touch in similar locations to OMT. | Other | Control group |
Primary outcome
Change in Fractionated Exhaled Nitric Oxide (FeNO) values as measured by NIOX FeNO device
Time frame: Baseline, after OMT treatment (up to 30 minutes), day 10
Change in Peak Expiratory Flow values as measured by EasyOne Air Spirometer device
Time frame: Baseline, after OMT treatment (up to 30 minutes), day 10
3 secondary outcomes
Change in Ease of breathing as measured by Post-OMT Questionnaire
Time frame: Baseline and day 10
Change in Rib Cage mobility as measured by Post-OMT Questionnaire
Time frame: Baseline and day 10
Change in chest tightness as measured by Post-OMT Questionnaire
Time frame: Baseline and day 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Asthma
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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. This study is not recruiting at the moment.
Nancy Wasserbauer-Kingston, DO principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMT and Light touch in people with Asthma, run by University Hospitals Cleveland Medical Center 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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 20 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fractionated Exhaled Nitric Oxide (FeNO) values as measured by NIOX FeNO device (time frame: Baseline, after OMT treatment (up to 30 minutes), day 10). The study lists 2 primary outcomes in all. 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 20 Apr 2026.