AsthmaBTRNCT01185275
A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)
An observational study of Asthma, run by Washington University School of Medicine at 8 sites in United States.
Trial summary
Clinical response, as defined by improvement in asthma quality of life, to bronchial thermoplasty in patients with severe refractory asthma can be predicted through the use of clinical, physiologic, biologic and imaging markers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Alair system
- Type of treatment
- Medical device
- How many people
- 133 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2010to 1 Oct 2019
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject Population - Severe Refractory Asthma
Who may be able to join
- Males or females age 18 or greater and less than 65
- Subject has asthma and is taking regular maintenance medication for past 12 months that includes:
- Inhaled corticosteroid (ICS) at a dosage greater than 1000μg beclomethasone per day or equivalent, AND long acting ß2-agonist (LABA) at a dosage of ≥100μg per day Salmeterol or equivalent.
- Other asthma medications such as leukotriene modifiers, or anti-IgE, are acceptable (Subjects on Xolair® must have been on Xolair for greater than 1 year).
- Asthma confirmed by: (a) b-agonist reversibility of FEV1 ≥ 12 % following 360mcg albuterol OR (b) methacholine FEV1 PC20 ≤ 8 mg/ml if not receiving an ICS or ≤ 16 mg/ml if receiving an ICS.
- FEV1 ≥ 50% predicted pre-bronchodilator.
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- Asthma symptoms on at least two days or one night per week over the last 2 weeks.
- Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
- Ability to undergo bronchoscopy in the opinion of the investigator.
- Ability and willingness to provide informed consent.
Who cannot join
- Asthma exacerbation (ED visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks.
- Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for asthma in the previous year.
- Chronic oral steroid therapy greater than 30 mg per day
- Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, untreated obstructive sleep apnea, Churg-Strauss syndrome, cardiac dysfunction, and allergic bronchopulmonary aspergillosis (total IgE of >1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation.
- Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
- Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke.
Show all 12Show fewer
- Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).
- Subject uses an internal or external pacemaker or cardiac defibrillator.
- Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, or nervous system, or immunodeficiency
- History of cigarette smoking with > 10 pack years total
- Use of investigative drugs or intervention trials in the 30 days prior to enrollment or during the duration of the study
- Any condition or compliance issue which in the opinion of the investigator might interfere with participation in the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
National Jewish Health
Denver, Colorado, 80206
Louisiana State University Health Sciences Center in New Orleans
New Orleans, Louisiana, 70112
Creighton University
Omaha, Nebraska
Washington University School of Medicine
St Louis, Missouri, 63110
University of Arizona
Tucson, Arizona
About this study
Clinical response, as defined by improvement in asthma quality of life, to bronchial thermoplasty in patients with severe refractory asthma can be predicted through the use of clinical, physiologic, biologic and imaging markers.
Read the detailed description
Primary Aim To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by improvement in asthma quality of life, in patients with severe refractory asthma.
Secondary Aims
- To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in severe exacerbations or healthcare utilization, in patients with severe refractory asthma.
- To evaluate if baseline clinical, physiologic, biologic and imaging markers are related to safety of bronchial thermoplasty in patients with severe refractory asthma.
- To evaluate and validate statistical models that predict response to bronchial thermoplasty in patients with severe refractory asthma.
- Conditions
- Asthma
- Being tested
- Alair system
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alair systemDevice
Bronchial thermoplasty
| Study group | Role | What they receive |
|---|---|---|
| Severe Asthma Patients | Severe asthma patients symptomatic despite high dose inhaled corticosteroid and long acting beta-agonist Receives: Device: Alair system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline predictors of response to bronchial thermoplasty defined by improvement in asthma quality of life, in patients with severe refractory asthma.
To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by improvement in asthma quality of life, in patients with severe refractory asthma.
Measured: 12 months following last bronchial thermoplasty treatment
Secondary outcomes (4)
Baseline predictors of severe exacerbations
To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in severe exacerbations, in patients with severe refractory asthma.
Measured: 12 months following last bronchial thermoplasty treatment
Baseline predictors of healthcare utilization
To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in healthcare utilization, in patients with severe refractory asthma.
Measured: 12 months following last bronchial thermoplasty treatment
Baseline predictors of safety of bronchial thermoplasty
To evaluate if baseline clinical, physiologic, biologic and imaging markers are related to safety of bronchial thermoplasty in patients with severe refractory asthma.
Measured: 12 months following last bronchial thermoplasty treatment
Predictive models of response to bronchial thermoplasty
To evaluate and validate statistical models that predict response to bronchial thermoplasty in patients with severe refractory asthma.
Measured: 12 months following last bronchial thermoplasty treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, National Jewish Health, University of Arizona, University of Chicago, Louisiana State University Health Sciences Center in New Orleans, University of Alabama at Birmingham, Creighton University
- Responsible party
- Sponsor
- Investigators
- Mario Castro, MD, MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185275
- Sponsor's protocol ID
- 10-0716- 201106118
- Acronym
- BTR
- Status last verified
- Nov 2020
- First submitted
- 21 Jun 2010
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Samant M, Krings JG, Lew D, Goss CW, Koch T, McGregor MC, Boomer J, Hall CS, Schechtman KB, Sheshadri A, Peterson S, Erzurum S, DePew Z, Morrow LE, Hogarth DK, Tejedor R, Trevor J, Wechsler ME, Sam A, Shi X, Choi J, Castro M. Use of Quantitative CT Imaging to Identify Bronchial Thermoplasty Responders. Chest. 2024 Apr;165(4):775-784. doi: 10.1016/j.chest.2023.12.015. Epub 2023 Dec 18.
PubMed 38123124
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)
- ClinicalTrials.gov ID
- NCT01185275
- Acronym / sponsor ID
- BTR / 10-0716- 201106118
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, National Jewish Health, University of Arizona, University of Chicago, Louisiana State University Health Sciences Center in New Orleans, University of Alabama at Birmingham, Creighton University
- Study start
- Aug 2010
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 19 Aug 2010 (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.
Clinical response, as defined by improvement in asthma quality of life, to bronchial thermoplasty in patients with severe refractory asthma can be predicted through the use of clinical, physiologic, biologic and imaging markers.
Detailed description
Primary Aim To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by improvement in asthma quality of life, in patients with severe refractory asthma.
Secondary Aims
- To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in severe exacerbations or healthcare utilization, in patients with severe refractory asthma.
- To evaluate if baseline clinical, physiologic, biologic and imaging markers are related to safety of bronchial thermoplasty in patients with severe refractory asthma.
- To evaluate and validate statistical models that predict response to bronchial thermoplasty in patients with severe refractory asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Asthma Patients | – | Device: Alair systemSevere asthma patients symptomatic despite high dose inhaled corticosteroid and long acting beta-agonist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject Population - Severe Refractory Asthma
Key inclusion criteria (10 listed)
- Males or females age 18 or greater and less than 65
- Subject has asthma and is taking regular maintenance medication for past 12 months that includes:
- Asthma confirmed by: (a) b-agonist reversibility of FEV1 ≥ 12 % following 360mcg albuterol OR (b) methacholine FEV1 PC20 ≤ 8 mg/ml if not receiving an ICS or ≤ 16 mg/ml if receiving an ICS.
- FEV1 ≥ 50% predicted pre-bronchodilator.
- Asthma symptoms on at least two days or one night per week over the last 2 weeks.
Key exclusion criteria (12 listed)
- Asthma exacerbation (ED visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks.
- Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for asthma in the previous year.
- Chronic oral steroid therapy greater than 30 mg per day
- Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, untreated obstructive sleep apnea, Churg-Strauss syndrome, cardiac dysfunction, and allergic bronchopulmonary aspergillosis (total IgE of >1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation.
- Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
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 |
|---|---|---|
| Alair systemBronchial thermoplasty | Device | Severe Asthma Patients |
Primary outcome
Baseline predictors of response to bronchial thermoplasty defined by improvement in asthma quality of life, in patients with severe refractory asthma.
Time frame: 12 months following last bronchial thermoplasty treatment
To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by improvement in asthma quality of life, in patients with severe refractory asthma.
4 secondary outcomes
Baseline predictors of severe exacerbations
Time frame: 12 months following last bronchial thermoplasty treatment
Baseline predictors of healthcare utilization
Time frame: 12 months following last bronchial thermoplasty treatment
Baseline predictors of safety of bronchial thermoplasty
Time frame: 12 months following last bronchial thermoplasty treatment
Predictive models of response to bronchial thermoplasty
Time frame: 12 months following last bronchial thermoplasty treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Derived from this study: PubMed 38123124Samant M, Krings JG, Lew D, Goss CW, Koch T, McGregor MC, Boomer J, Hall CS, Schechtman KB, Sheshadri A, Peterson S, Erzurum S, DePew Z, Morrow LE, Hogarth DK, Tejedor R, Trevor J, Wechsler ME, Sam A, Shi X, Choi J, Castro M. Use of Quantitative CT Imaging to Identify Bronchial Thermoplasty Responders. Chest. 2024 Apr;165(4):775-784. doi: 10.1016/j.chest.2023.12.015. Epub 2023 Dec 18.
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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.
Mario Castro, MD, MPH principal investigator
Washington University School of Medicine
8 sites 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 Washington University School of Medicine at 8 sites 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Baseline predictors of response to bronchial thermoplasty defined by improvement in asthma quality of life, in patients with severe refractory asthma. (time frame: 12 months following last bronchial thermoplasty treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01185275, which also lists 1 linked publication.
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 27 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.