AsthmaNCT02241265
Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma
An observational study of Asthma, run by University of Oklahoma at 1 site in United States.
Trial summary
The investigators hypothesis is that there will be improvement in FEV1 in patients with severe asthma. This is a retrospective data study that reviews preexisting medical records; no patients will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective review of Asthma Patients' records
Who may be able to join
- >18 years of age
- severe asthma diagnosis
- decreased FEV1
Who cannot join
- < 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trials Manager contact
United States1 site, 1 recruiting
- Recruiting
OUHSC
Oklahoma City, Oklahoma, 73104
Brent Brown, MD, 405-271-6173
Clinical Trials Manager, research@ouhsc.edu
About this study
The investigators hypothesis is that there will be improvement in FEV1 in patients with severe asthma. This is a retrospective data study that reviews preexisting medical records; no patients will be enrolled.
Read the detailed description
The investigators plan is to retrospectively evaluate spirometry on patients with severe asthma who have undergone bronchial thermoplasty. The procedure will have been done according to the recommended protocol of three separate sessions. For each patient all available spirometric data obtained before and after thermoplasty will be used. Data will be collected from two centers, OU Medical Center and St. Francis Hospital in Tulsa, OK. All procedures done at St. Francis have been performed by a single physician and he is providing their spirometric data for the investigators study. The following data will be collected for all participants undergoing bronchial thermoplasty: Age, height, sex, weight, medical history, smoking history, baseline spirometry before and after bronchodilators, post thermoplasty spirometry before and after bronchodilators.
- Conditions
- Asthma
- Keywords
- asthma, thermoplasty
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Past Bronchial Thermoplasty data | Data will be collected from records of patients who, in the past, have undergone bronchial thermoplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints are improvements in prebronchodilator FEV1 and FVC.
The primary endpoints are improvements in prebronchodilator FEV1 and FVC by 12% predicted.
Measured: 1 year after thermoplasty
Secondary outcomes (1)
Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness.
Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness by 12% predicted.
Measured: 1 year after thermoplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2026 (estimated)
- Study completionSep 2026 (estimated)
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.
- More trials run by University of OklahomaThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Brown, MD, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241265
- Sponsor's protocol ID
- 3790
- Other IDs
- 3790
- Status last verified
- Feb 2025
- First submitted
- 5 May 2014
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data may only be shared upon review of OUHSC Legal office and IRB. Data sharing agreement required. Contact research@ouhsc.edu to initiate data requests. No personally identifiable data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma
- ClinicalTrials.gov ID
- NCT02241265
- Acronym / sponsor ID
- 3790
- Conditions
- Asthma
- Keywords
- asthma, thermoplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Sep 2014 (estimated)
- 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.
The investigators hypothesis is that there will be improvement in FEV1 in patients with severe asthma. This is a retrospective data study that reviews preexisting medical records; no patients will be enrolled.
Detailed description
The investigators plan is to retrospectively evaluate spirometry on patients with severe asthma who have undergone bronchial thermoplasty. The procedure will have been done according to the recommended protocol of three separate sessions. For each patient all available spirometric data obtained before and after thermoplasty will be used. Data will be collected from two centers, OU Medical Center and St. Francis Hospital in Tulsa, OK. All procedures done at St. Francis have been performed by a single physician and he is providing their spirometric data for the investigators study. The following data will be collected for all participants undergoing bronchial thermoplasty: Age, height, sex, weight, medical history, smoking history, baseline spirometry before and after bronchodilators, post thermoplasty spirometry before and after bronchodilators.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Past Bronchial Thermoplasty data | – | –Data will be collected from records of patients who, in the past, have undergone bronchial thermoplasty. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective review of Asthma Patients' records
Key inclusion criteria (3 listed)
- >18 years of age
- severe asthma diagnosis
- decreased FEV1
Key exclusion criteria (1 listed)
- < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoints are improvements in prebronchodilator FEV1 and FVC.
Time frame: 1 year after thermoplasty
The primary endpoints are improvements in prebronchodilator FEV1 and FVC by 12% predicted.
1 secondary outcome
Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness.
Time frame: 1 year after thermoplasty
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 10 Feb 2025.
- Individual participant dataSharing planned: No. Deidentified data may only be shared upon review of OUHSC Legal office and IRB. Data sharing agreement required. Contact research@ouhsc.edu to initiate data requests. No personally identifiable data will be shared.
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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.
Clinical Trials Manager contact
Brent Brown, MD principal investigator
OUHSC
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 Asthma, run by University of Oklahoma 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 10 Feb 2025. 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 Brent Brown, MD (405-271-6173, brent-brown@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoints are improvements in prebronchodilator FEV1 and FVC. (time frame: 1 year after thermoplasty). 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 10 Feb 2025.