AsthmaTHERMASCORTNCT02464995
Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
A study testing Bronchial thermoplasty with the Alair System in people with Asthma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations. This will be a single center randomized and controlled study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Bronchial thermoplasty with the Alair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2015to 9 Nov 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5
- Four or more bursts of systemic corticosteroids >3 days each in the previous year
- Willingness and ability to give written informed consent
Who cannot join
- Current smoker and former smoker > 10 pack years total smoking history
- Participation in another clinical trial within the prior 4 months
- Omalizumab therapy within the prior 4 months
- Allergic bronchopulmonary aspergillosis
- Patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (> 60 mg equivalent prednisolone) more than one month in the previous year
- Post-bronchodilator FEV1 of less than 30%
Show all 16Show fewer
- Past diagnosis of COPD and chronic respiratory insufficiency
- Known coagulopathy or platelet dysfunction
- Use of anticoagulants
- Use of an internal or external pacemaker or internal cardiac defibrillator
- Contraindication to perform bronchoscopy
- Contraindication to perform general anesthesia
- Significant cardiovascular disease
- Current or recent respiratory tract infection resolved less than 4 weeks
- Known cancer or cancer history less than 12 months
- Pregnancy and nursing mother
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Naji KHAYATH, PhD, naji.khayath@chru-strasbourg.fr
About this study
The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations.
This will be a single center randomized and controlled study. Thirty subjects with severe asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic corticosteroids >3 days each in the previous year) will be randomized 1:1 to either the thermoplasty group (bronchial thermoplasty and medical management) or control group (medical management only).
- Conditions
- Asthma
- Being tested
- Bronchial thermoplasty with the Alair System
- Keywords
- Asthma,, Asthma exacerbation, Bronchial thermoplasty
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial thermoplasty with the Alair SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Thermoplasty group | Experimental | Procedure: Bronchial thermoplasty with the Alair System and conventional therapy Receives: Device: Bronchial thermoplasty with the Alair System |
| Control group | No intervention | Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe exacerbation rate (change from baseline)
A severe exacerbation is defined by a burst of systemic corticosteroids >3 days
Measured: Baseline, 6 months and 12 months after the last thermoplasty procedure
Secondary outcomes (8)
Time to the first severe asthma exacerbation
Measured: anytime
Mean oral glucocorticosteroid dose (mg equivalent prednisone)
Measured: Baseline, 6 and 12 Months
Mild exacerbation rate
Measured: Baseline, 6 and 12 Months
Pre- and post-bronchodilator FEV1
Measured: Baseline, 6 and 12 Months
Asthma Control Questionnaire (ACQ) Score
Measured: Baseline, 3, 6, 9 and 12 Months
Asthma Quality of Life Questionnaire (AQLQ) Score
Measured: Baseline, 3, 6, 9 and 12 Months
Structural airway remodeling using CT
Measured: Baseline and 12 Months
Inflammatory cells and markers in induced sputum
Measured: Time Frame: Baseline and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start9 Jun 2015
- Primary completion9 Nov 2020 (estimated)
- Study completion9 Nov 2022 (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 Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464995
- Sponsor's protocol ID
- 5886
- Acronym
- THERMASCORT
- Status last verified
- May 2019
- First submitted
- 3 Jun 2015
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
- ClinicalTrials.gov ID
- NCT02464995
- Acronym / sponsor ID
- THERMASCORT / 5886
- Conditions
- Asthma
- Keywords
- Asthma,, Asthma exacerbation, Bronchial thermoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 9 Nov 2020 (estimated)
- Study completion
- 9 Nov 2022 (estimated)
- First posted
- 8 Jun 2015 (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 purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations.
This will be a single center randomized and controlled study. Thirty subjects with severe asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic corticosteroids >3 days each in the previous year) will be randomized 1:1 to either the thermoplasty group (bronchial thermoplasty and medical management) or control group (medical management only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermoplasty group | Experimental | Device: Bronchial thermoplasty with the Alair SystemProcedure: Bronchial thermoplasty with the Alair System and conventional therapy |
| Control group | No intervention | –Conventional therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5
- Four or more bursts of systemic corticosteroids >3 days each in the previous year
- Willingness and ability to give written informed consent
Key exclusion criteria (16 listed)
- Current smoker and former smoker > 10 pack years total smoking history
- Participation in another clinical trial within the prior 4 months
- Omalizumab therapy within the prior 4 months
- Allergic bronchopulmonary aspergillosis
- Patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (> 60 mg equivalent prednisolone) more than one month in the previous year
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 thermoplasty with the Alair System | Device | Thermoplasty group |
Primary outcome
Severe exacerbation rate (change from baseline)
Time frame: Baseline, 6 months and 12 months after the last thermoplasty procedure
A severe exacerbation is defined by a burst of systemic corticosteroids >3 days
8 secondary outcomes
Time to the first severe asthma exacerbation
Time frame: anytime
Mean oral glucocorticosteroid dose (mg equivalent prednisone)
Time frame: Baseline, 6 and 12 Months
Mild exacerbation rate
Time frame: Baseline, 6 and 12 Months
Pre- and post-bronchodilator FEV1
Time frame: Baseline, 6 and 12 Months
Asthma Control Questionnaire (ACQ) Score
Time frame: Baseline, 3, 6, 9 and 12 Months
Asthma Quality of Life Questionnaire (AQLQ) Score
Time frame: Baseline, 3, 6, 9 and 12 Months
Structural airway remodeling using CT
Time frame: Baseline and 12 Months
Inflammatory cells and markers in induced sputum
Time frame: Time Frame: Baseline and 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial thermoplasty with the Alair System in people with Asthma, run by University Hospital, Strasbourg, France at 1 site in France.
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 16 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: status not confirmed, as of the sponsor's last update on 30 May 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe exacerbation rate (change from baseline) (time frame: Baseline, 6 months and 12 months after the last thermoplasty procedure). 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 30 May 2019.