AsthmaBTGRNCT02104856
Bronchial Thermoplasty Global Registry
An observational study of Asthma, run by Boston Scientific Corporation at 19 sites in 8 countries.
Trial summary
The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Alair System (Bronchial Thermoplasty)
- Type of treatment
- Medical device
- How many people
- 158 participants
- Where
- 19 sitesin 8 countries
- Study dates
- Jan 2014to 26 Jun 2019
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing BT according to labeled indications will be approached to participate in the Registry.
Who may be able to join
- Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment according to the Alair System DFU.
- Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the registry requirements.
Who cannot join
- 1. Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Germany4 sites
Universitätsklinikum Bonn
Bonn, D-53105
Ruhrlandklinik, Westdeutsches Lungenzentrum
Essen, 45239
Thoraxklinik, University of Heidelberg
Heidelberg, D-69126
University Hospital of Regensburg
Regensburg, 93042
Spain4 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Germans Trias I Puyol
Barcelona, 08916
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Australia3 sites
Peninsula Health
Frankston, Victoria, 3199
Royal Brisbane and Women's Hospital
Herston, Queensland, 4001
Macquarie University Private Hospital
North Ryde, New South Wales, 2109
Italy3 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona, 60126
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
Aricispedale Santa Maria Nuova
Reggio Emilia, 41223
United Kingdom2 sites
Gartnavel General Hospital
Glasgow, Scotland, G12 OYN
Wythenshawe Hospital University of Manchester
Manchester, M23 9LT
South Africa1 site
University of Cape Town Groote Shuur Hospital
Cape Town, 7925
About this study
Official title: Bronchial Thermoplasty (BT) Global Registry
The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.
Read the detailed description
This Registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing BT treatment in the "real world" setting. Patients will be recruited at participating study centers that offer BT as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications.
The Registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. The treatment period is from the date of the first BT procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). The post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) BT procedure for 2-years of follow-up.
The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
- Conditions
- Asthma
- Being tested
- Alair System (Bronchial Thermoplasty)
- Keywords
- Asthma, Bronchial Thermoplasty, Registry, Device, Alair
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alair System (Bronchial Thermoplasty)Device
| Study group | Role | What they receive |
|---|---|---|
| Alair System (Bronchial Thermoplasty) | Asthma patients undergoing Bronchial Thermoplasty treatment with commercially available Alair device as per Directions For Use. Receives: Device: Alair System (Bronchial Thermoplasty) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who experience severe asthma exacerbations
The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
Measured: 2 years
Secondary outcomes (15)
Asthma Quality of Life Questionnaire (AQLQ) score
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) scores will be summarized descriptively for Year 1 and Year 2 post-BT.
Measured: 2 years
Asthma Control Test (ACT) score
Change from baseline in Asthma Control Test (ACT) scores will be summarized descriptively for Year 1 and Year 2 post-BT.
Measured: 2 years
Emergency department visits for asthma symptoms
Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.
Measured: 2 years
Hospitalizations for asthma symptoms
Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.
Measured: 2 years
Unscheduled office visits including urgent care visits for asthma symptoms.
Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.
Measured: 2 years
Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1)
Pre- and post-bronchodilator FEV1 will be summarized for Year 1 and Year 2 post-BT treatment (% predicted and absolute value). Change from baseline will also be summarized.
Measured: 2 years
Respiratory Adverse Events
Separated by treatment period and post-treatment period
Measured: 2 years
Lung Volumes
Collected at sites where it is standard of care
Measured: 2 years
Diffusion Capacity
Collected at sites where it is standard of care
Measured: 2 years
Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.)
Collect asthma maintenance medications at all sites
Measured: 2 years
Patient satisfaction survey score
Two question survey collected at 12 month and 24 month annual visit
Measured: 2 years
Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold)
Collected at sites where it is standard of care
Measured: 2 years
Sputum eosinophils
Collected at sites where it is standard of care
Measured: 2 years
Exhaled nitric oxide (eNO)
Collected at sites where it is standard of care
Measured: 2 years
Methacholine challenge (Methacholine PC20)
Collected at sites where it is standard of care
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJan 2014
- Primary completion26 Jun 2019
- Study completion26 Jun 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
- Other
- Enrolment
- 158 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Niven, MD, Principal investigator, Wythenshawe Hospital - University of ManchesterAlfons Torrego, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauFelix Herth, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104856
- Sponsor's protocol ID
- E7086
- Acronym
- BTGR
- Status last verified
- Sep 2019
- First submitted
- 2 Apr 2014
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torrego A, Herth FJ, Munoz-Fernandez AM, Puente L, Facciolongo N, Bicknell S, Novali M, Gasparini S, Bonifazi M, Dheda K, Andreo F, Votruba P, Langton D, Flandes J, Fielding D, Bonta PI, Skowasch D, Schulz C, Darwiche K, McMullen E, Grubb GM, Niven R. Bronchial Thermoplasty Global Registry (BTGR): 2-year results. BMJ Open. 2021 Dec 16;11(12):e053854. doi: 10.1136/bmjopen-2021-053854.
PubMed 34916324
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Thermoplasty (BT) Global Registry
- ClinicalTrials.gov ID
- NCT02104856
- Acronym / sponsor ID
- BTGR / E7086
- Conditions
- Asthma
- Keywords
- Asthma, Bronchial Thermoplasty, Registry, Device, Alair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 4 Apr 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 primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.
Detailed description
This Registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing BT treatment in the "real world" setting. Patients will be recruited at participating study centers that offer BT as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications.
The Registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. The treatment period is from the date of the first BT procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). The post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) BT procedure for 2-years of follow-up.
The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alair System (Bronchial Thermoplasty) | – | Device: Alair System (Bronchial Thermoplasty)Asthma patients undergoing Bronchial Thermoplasty treatment with commercially available Alair device as per Directions For Use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing BT according to labeled indications will be approached to participate in the Registry.
Key inclusion criteria (2 listed)
- Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment according to the Alair System DFU.
- Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the registry requirements.
Key exclusion criteria (1 listed)
- 1. Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.
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 System (Bronchial Thermoplasty) | Device | Alair System (Bronchial Thermoplasty) |
Primary outcome
Proportion of patients who experience severe asthma exacerbations
Time frame: 2 years
The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
15 secondary outcomes
Asthma Quality of Life Questionnaire (AQLQ) score
Time frame: 2 years
Asthma Control Test (ACT) score
Time frame: 2 years
Emergency department visits for asthma symptoms
Time frame: 2 years
Hospitalizations for asthma symptoms
Time frame: 2 years
Unscheduled office visits including urgent care visits for asthma symptoms.
Time frame: 2 years
Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1)
Time frame: 2 years
Respiratory Adverse Events
Time frame: 2 years
Lung Volumes
Time frame: 2 years
Diffusion Capacity
Time frame: 2 years
Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.)
Time frame: 2 years
Patient satisfaction survey score
Time frame: 2 years
Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold)
Time frame: 2 years
Sputum eosinophils
Time frame: 2 years
Exhaled nitric oxide (eNO)
Time frame: 2 years
Methacholine challenge (Methacholine PC20)
Time frame: 2 years
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 Sep 2019.
- Derived from this study: PubMed 34916324Torrego A, Herth FJ, Munoz-Fernandez AM, Puente L, Facciolongo N, Bicknell S, Novali M, Gasparini S, Bonifazi M, Dheda K, Andreo F, Votruba P, Langton D, Flandes J, Fielding D, Bonta PI, Skowasch D, Schulz C, Darwiche K, McMullen E, Grubb GM, Niven R. Bronchial Thermoplasty Global Registry (BTGR): 2-year results. BMJ Open. 2021 Dec 16;11(12):e053854. doi: 10.1136/bmjopen-2021-053854.
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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.
Robert Niven, MD principal investigator
Wythenshawe Hospital - University of Manchester
Alfons Torrego, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Felix Herth, MD principal investigator
Heidelberg University
19 sites in 8 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 19 sites in 8 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 2 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 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Spain, Australia, Italy, United Kingdom and 3 more countries. 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?
Proportion of patients who experience severe asthma exacerbations (time frame: 2 years). 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 NCT02104856, 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 Sep 2019; AzTrials last refreshed its copy on 4 Nov 2026.