AsthmaNCT03243292
Bronchial Thermoplasty 10+ Year Study
An observational study of Asthma, run by Boston Scientific Corporation at 17 sites in 5 countries.
Trial summary
To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Bronchial Thermoplasty
- How many people
- 192 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 11 Dec 2017to 10 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects that participated in one one or more of the prior studies (AIR, RISA, or AIR2) will be invited to participate in this study.
Who may be able to join
- Subjects previously enrolled in AIR, RISA or AIR2
- Subjects who received active BT treatment and had last BT treatment at least 10 years and 6 weeks prior to enrollment
- Control/Sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks
- Subject is able to read, understand and sign a written Informed Consent to participate in the Study and able to comply with the study requirements
Who cannot join
- Severe asthma exacerbation or chest infection in the past 4 weeks. Subject entry into this study should be delayed until free from severe asthma exacerbation or chest infection for a minimum of 4 weeks.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States6 sites
Pulmonary Associates of Northern Virginia
Arlington, Virginia, 22205
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202-268
University of Southern California
Los Angeles, California, 90033
Regions Hospital Health Partners Specialty Center
Saint Paul, Minnesota, 55130
Washington University Medical Center
St Louis, Missouri, 63110-1093
Brazil4 sites
Imandade Santa Casa de Misercordia
Pôrto Alegre, Rio Grande do Sul, 90035074
Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides
Pôrto Alegre, 90480-000
Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ
Rio de Janeiro, 21949-900
Faculdade da Medicina do ABC
Santo André, São Paulo, 09060-650
United Kingdom4 sites
Chelsea and Westminster Hospital
Chelsea, London, SW10 9NH
Gartnavel General Hospital
Glasgow, Scotland, G12 OYN
University of Leicester Glenfield Hospital
Leicester, LE5 4PW
Wythenshawe Hospital, University of Manchester
Manchester, M23 9LT
Canada2 sites
Montreal Chest Institute
Montreal, Quebec, H4A 3J1
Institute Universitaire de Cardiologie et Pneumologie de Quebec
Québec, Quebec, G1V4G5
Netherlands1 site
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
About this study
Official title: Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies
To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.
Read the detailed description
Compare rates of severe asthma exacerbations of subjects during the first and fifth year after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 months period prior to enrollment.
Compare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to examine if there are any clinically significant post-treatment respiratory changes following BT defined as bronchiectasis or bronchial stenosis.
- Conditions
- Asthma
- Being tested
- Bronchial Thermoplasty
- Keywords
- Bronchial Thermoplasty, Alair, Registry
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial ThermoplastyOther
patients had radio frequency ablation of the smooth muscle for asthma
| Study group | Role | What they receive |
|---|---|---|
| Treated | Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2) Receives: Other: Bronchial Thermoplasty | |
| Control | Subjects that participated in prior study (AIR) or (RISA) but did not receive Bronchial Thermoplasty Treatment. Determine if the Control group of subjects asthma has progressed any different from those subjects treated with BT. Receives: Other: Bronchial Thermoplasty | |
| Sham | Subjects that participated in the AIR2 study, were blinded and did not receive the treatment. Determine if the Sham group of subjects asthma has progressed any different from those subjects treated with BT. Receives: Other: Bronchial Thermoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.
Following BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary Volumetric HRCT scan at the BT 10+study visit in those3 subjects who had baseline Volumetric HRCT scan in the AIR2 study. Baseline and 10+ year HRCTs are to be read by an independent radiologist and also assessed by an independent pulmonologist.
Measured: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.
Durability of the treatment effect by comparing the proportion of subjects who experience severe asthma exacerbations during the first and fifth years after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 month period prior to the BT 10+ study visit.
Measured: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Secondary outcomes (9)
Severe asthma exacerbation rates exacerbations
evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
Measured: One day visit
Severe asthma exacerbation rates subject
evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
Measured: One day visit
Severe asthma exacerbation rates year
evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
Measured: One day visit
rates of emergency room visits for respiratory adverse events
evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
Measured: One day visit
proportion of subjects with emergency room visits for respiratory adverse events
evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
Measured: One day visit
Rates of hospitalizations for respiratory adverse events
evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
Measured: One day visit
Proportion of subjects with hospitalizations for respiratory adverse events
evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
Measured: One day visit
Rates of Respiratory Serious Adverse Events (SAEs)
evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
Measured: One day visit
Proportion of subjects with respiratory SAEs)
evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
Measured: One day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start11 Dec 2017
- Primary completion10 Jan 2019
- Study completion10 Jan 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 Boston Scientific CorporationThe 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
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Bowman, MD, Study director, Medical Director, Boston Scientific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243292
- Sponsor's protocol ID
- 92115848
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2017
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chaudhuri R, Rubin A, Sumino K, Lapa E Silva JR, Niven R, Siddiqui S, Klooster K, McEvoy C, Shah PL, Simoff M, Khatri S, Barbers R, Mark Grubb G, McMullen EA, Olson JL, Laviolette M; BT10+ Study Group. Safety and effectiveness of bronchial thermoplasty after 10 years in patients with persistent asthma (BT10+): a follow-up of three randomised controlled trials. Lancet Respir Med. 2021 May;9(5):457-466. doi: 10.1016/S2213-2600(20)30408-2. Epub 2021 Jan 29.
PubMed 33524320
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies
- ClinicalTrials.gov ID
- NCT03243292
- Acronym / sponsor ID
- 92115848
- Conditions
- Asthma
- Keywords
- Bronchial Thermoplasty, Alair, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 8 Aug 2017 (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.
To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.
Detailed description
Compare rates of severe asthma exacerbations of subjects during the first and fifth year after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 months period prior to enrollment.
Compare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to examine if there are any clinically significant post-treatment respiratory changes following BT defined as bronchiectasis or bronchial stenosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treated | – | Other: Bronchial ThermoplastySubjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2) |
| Control | – | Other: Bronchial ThermoplastySubjects that participated in prior study (AIR) or (RISA) but did not receive Bronchial Thermoplasty Treatment. Determine if the Control group of subjects asthma has progressed any different from those subjects treated with BT. |
| Sham | – | Other: Bronchial ThermoplastySubjects that participated in the AIR2 study, were blinded and did not receive the treatment. Determine if the Sham group of subjects asthma has progressed any different from those subjects treated with BT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects that participated in one one or more of the prior studies (AIR, RISA, or AIR2) will be invited to participate in this study.
Key inclusion criteria (4 listed)
- Subjects previously enrolled in AIR, RISA or AIR2
- Subjects who received active BT treatment and had last BT treatment at least 10 years and 6 weeks prior to enrollment
- Control/Sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks
- Subject is able to read, understand and sign a written Informed Consent to participate in the Study and able to comply with the study requirements
Key exclusion criteria (1 listed)
- Severe asthma exacerbation or chest infection in the past 4 weeks. Subject entry into this study should be delayed until free from severe asthma exacerbation or chest infection for a minimum of 4 weeks.
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 |
|---|---|---|
| Bronchial Thermoplastypatients had radio frequency ablation of the smooth muscle for asthma | Other | Control, Sham, Treated |
Primary outcome
Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.
Time frame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Following BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary Volumetric HRCT scan at the BT 10+study visit in those3 subjects who had baseline Volumetric HRCT scan in the AIR2 study. Baseline and 10+ year HRCTs are to be read by an independent radiologist and also assessed by an independent pulmonologist.
Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.
Time frame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Durability of the treatment effect by comparing the proportion of subjects who experience severe asthma exacerbations during the first and fifth years after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 month period prior to the BT 10+ study visit.
9 secondary outcomes
Severe asthma exacerbation rates exacerbations
Time frame: One day visit
Severe asthma exacerbation rates subject
Time frame: One day visit
Severe asthma exacerbation rates year
Time frame: One day visit
rates of emergency room visits for respiratory adverse events
Time frame: One day visit
proportion of subjects with emergency room visits for respiratory adverse events
Time frame: One day visit
Rates of hospitalizations for respiratory adverse events
Time frame: One day visit
Proportion of subjects with hospitalizations for respiratory adverse events
Time frame: One day visit
Rates of Respiratory Serious Adverse Events (SAEs)
Time frame: One day visit
Proportion of subjects with respiratory SAEs)
Time frame: One day visit
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 13 Jul 2020.
- Derived from this study: PubMed 33524320Chaudhuri R, Rubin A, Sumino K, Lapa E Silva JR, Niven R, Siddiqui S, Klooster K, McEvoy C, Shah PL, Simoff M, Khatri S, Barbers R, Mark Grubb G, McMullen EA, Olson JL, Laviolette M; BT10+ Study Group. Safety and effectiveness of bronchial thermoplasty after 10 years in patients with persistent asthma (BT10+): a follow-up of three randomised controlled trials. Lancet Respir Med. 2021 May;9(5):457-466. doi: 10.1016/S2213-2600(20)30408-2. Epub 2021 Jan 29.
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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.
Thomas Bowman, MD study director
Medical Director, Boston Scientific
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Boston Scientific Corporation at 17 sites in 5 countries.
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 4 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: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Brazil, United Kingdom, Canada, Netherlands. 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?
Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT. (time frame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.). 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?
On the ClinicalTrials.gov record for NCT03243292, 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 13 Jul 2020; AzTrials last refreshed its copy on 31 Oct 2026.