AsthmaTASMANCT02225392

Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma

A study testing Bronchial thermoplasty and Alair system (Boston Scientific, USA) in people with Asthma and Bronchial Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Approximately 5% of asthma patients suffer from severe asthma that is characterized by frequent asthma exacerbations resulting in significant morbidity and excessive utilisation of health care resources. Therefore, there is a strong need for improved therapeutic strategies for these patients. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma, Bronchial Asthma
What is being tested?: Bronchial thermoplasty and Alair system (Boston Scientific, USA)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 3 sitesin 2 countries
Study dates: Apr 2014to Dec 2019
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

Males or females age 18 or greater and 65 or less
The diagnosis of asthma confirmed by at least one of the following as assessed at least once during the past 5 years before the study:
Reversibility to β2-agonists ≥12% predicted and ≥200ml after 400μg inhaled salbutamol or equivalent
Bronchial hyper-responsiveness to methacholine or histamine
Peak-flow variability of >20% over a period of 14 days
Fall in FEV1 >12% and >200ml when tapering treatment (ICS, oral steroid, LABA and/or LTRA).

Show all 17Show fewer

Subject is taking regular maintenance medication (GINA step 4-5) for past 6 months that includes:
Inhaled corticosteroid at a dosage ≥500μg fluticasone equivalent per day AND
Long acting ß2-agonist at a dosage of ≥100μg per day salmeterol dose aerosol or equivalent).
Per protocol bronchial hyper-responsiveness to methacholine (PC20<4 mg/ml)
Other asthma medications are acceptable (such as Leukotriene modifiers, Theophylline, Omalizumab treatment (or discontinuation for at least 6 months) Systemic corticosteroid use (≤20mg/day prednisone equivalent))
Pre-bronchodilator FEV1 ≥50% predicted (stabilized on ICS/LABA) and post-bronchodilator FEV1 ≥60%
ACQ >1,5 for 2 weeks
Non-smoker for 1 year or more (former smoker ≤15 pack years)
Ability to undergo bronchoscopy and BT in the opinion of the investigator.
Ability and willingness to provide informed consent.
For women of childbearing potential: non pregnant, non-lactating, and agree to practice an adequate birth control method for the duration of the study.

Who cannot join

Asthma exacerbation during the prior 4 weeks.
Subject has 5 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for mechanical or endotracheal intubation for asthma in the previous year.
Respiratory tract infection within past 4 weeks
Subject has a known sensitivity to medications required to perform bronchoscopy
Subject is using immunosuppressant therapy other than oral steroid therapy
Subject is on anticoagulant medication including anti-platelet agents.

Show all 19Show fewer

Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR >1.5).
Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (total IgE of >1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis).
Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray. Bronchiectasis on HR-CT-of the chest, both centrally or peripherally will be excluded.
Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke at the discretion of the investigator
Subject has uncontrolled hypertension (>200mmHg systolic or >100mmHg diastolic pressure).
Subject uses an internal or external pacemaker or cardiac defibrillator.
Other chronic diseases that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. liver, kidney, or nervous system
Current smokers, and a history of cigarette smoking with >15 pack years total
Use of investigative drugs or intervention trials in the 4 months prior to enrolment or during the duration of the study
Any condition or compliance issue which in the opinion of the investigator might interfere with participation inthe study
BMI >35
Pre-bronchodilator FEV1 <1.2L
Extreme coughing

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Netherlands2 sites

Academisch Medisch Centrum
Amsterdam, North Holland, 1105 AZ
University Medical Center Groningen
Groningen, 9700 RB

Other trials in Netherlands

United Kingdom1 site

Royal Brompton Hospital
London, SW3 6NP

Other trials in United Kingdom

About this study

Bronchial Thermoplasty (BT) is a novel, innovative device-based treatment of severe asthma that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy.

Hypothesis:

BT-induced clinical improvement in severe asthma is a consequence of reduction in airway smooth muscle (ASM) mass and (contractile/immunomodulatory) function, inflammation, neural innervation and/or vascular integrity resulting in altered airway remodelling. BT target identification and severe asthma phenotyping are critical for improved patient selection for BT and fundamental to discover novel, specific signalling pathways active in severe asthma.

Read the detailed description

This study has a two-fold purpose:

to unravel the targets of BT in severe asthma (how does it work?) which is fundamental for better patient selection (who benefits most?) and further improvement of BT technology and novel asthma therapy development (how to treat better?). These objectives can only be achieved by linking patient-reported outcomes to airway structure/function, which is the principal aim of the study proposed.
to investigate clinical outcome analyses

Conditions: Asthma, Bronchial Asthma
Being tested: Bronchial thermoplasty, Alair system (Boston Scientific, USA)
Keywords: Bronchial thermoplasty, Severe asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bronchial thermoplastyProcedure or surgery
Bronchial thermoplasty (BT) will be performed using the Alair system (Boston Scientific, USA). Patients will undergo 3 bronchoscopy procedures with BT at least 3 weeks apart. Treatment sessions are designed to address different lobes of the lung with the right lower lobe treated during the first bronchoscopy, the left lower lobe treated during the second bronchoscopy, and both the right and left upper lobes treated in the third and final bronchoscopy. The right middle lobe and proximal airways including RC2 are left untreated.
Alair system (Boston Scientific, USA)Device
The alair system consist of a controller and a bastket catheter.

Study groups in NCT02225392
Study group	Role	What they receive
Delayed bronchial thermoplasty	Active comparator	After randomisation they will wait for 25 weeks (control group) and then start with bronchial thermoplasty. Bronchial thermoplasty (BT) will be performed using the Alair system (Boston Scientific, USA). Patients will undergo 3 bronchoscopy procedures with BT at least 3 weeks apart. Treatment sessions are designed to address different lobes of the lung with the right lower lobe treated during the first bronchoscopy, the left lower lobe treated during the second bronchoscopy, and both the right and left upper lobes treated in the third and final bronchoscopy. The right middle lobe and proximal airways including RC2 are left untreated. Receives: Procedure: Bronchial thermoplasty; Device: Alair system (Boston Scientific, USA)
Immediate bronchial thermoplasty	Experimental	After randomisation they start immediate with bronchial thermoplasty treatment. Bronchial thermoplasty (BT) will be performed using the Alair system (Boston Scientific, USA). Patients will undergo 3 bronchoscopy procedures with BT at least 3 weeks apart. Treatment sessions are designed to address different lobes of the lung with the right lower lobe treated during the first bronchoscopy, the left lower lobe treated during the second bronchoscopy, and both the right and left upper lobes treated in the third and final bronchoscopy. The right middle lobe and proximal airways including RC2 are left untreated. Receives: Procedure: Bronchial thermoplasty; Device: Alair system (Boston Scientific, USA)

What is being measured

The primary outcome is the main question the study is designed to answer.

The change in airway smooth muscle (ASM) mass between immediate BT treated and the control group (N=20, randomized)
The change in ASM mass as determined by the percentage of ASM surface area in airway biopsies between:
- the immediate BT group and
- the delayed BT group = control group
Measured: Baseline, week 25

Secondary outcomes (18)

The change in ASM mass in airway biopsies before and after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Change in ASM mass in endobronchial biopsies before and after bronchial thermoplasty treatment
Measured: Baseline, 25 weeks
The change in structural airway remodelling after and during bronchial thermoplasty treatment
Optical Coherence Tomography (OCT)- and/or Radial Endobronchial ultrasound (rEBUS)-determined changes in structural airway remodelling.
Measured: Baseline, week 25
The change in pre-and post bronchodilator FEV1 and related % reversibility between immediate BT treated and control group (N=20, randomized)
Measured: Baseline, 24 week
The change in PC20 methacholine between immediate BT treated and control group (N=20, randomized)
Measured: Baseline, 24 week
The change in Fraction of exhaled nitric oxide (FeNO) between immediate BT treated and control group (N=20, randomized)
Measured: Baseline, 24 week
The change in asthma control questionnaire (ACQ) between immediate BT treated and control group (N=20, randomized)
Measured: Baseline, 24 week
The change in - asthma related quality of life questionnaire (AQLQ) between immediate BT treated and control group (N=20, randomized)
Measured: Baseline, 24 week
The change in health care utilization between immediate BT treated and control group (N=20, randomized)
Measured: Baseline, 24 week
The change in rescue medication use between immediate BT treated and control group (N=20, randomized)
Measured: Baseline, 24 week
The change in inflammatory cell density/counts in biopsy, BAL and induced sputum between immediate BT treated and control group (N=20, randomized)
Measured: Baseline, 25 week
The change in pre-and post bronchodilator FEV1 and related % reversibility after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Measured: Baseline, 24 week
The change in PC20 methacholine after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Measured: Baseline, 24 week
The change in Fraction of exhaled nitric oxide (FeNO) after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Measured: Baseline, 24 week
The change in asthma control questionnaire (ACQ) after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Measured: Baseline, 24 week
The change in asthma related quality of life questionnaire (AQLQ) after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Measured: Baseline, 24 week
The change in health care utilization after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Measured: Baseline, 24 week
The change in rescue medication use after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Measured: Baseline, 24 week
The change in inflammatory cell density/counts in biopsy, BAL and induced sputum before and after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Measured: Baseline, 25 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Dec 2019

First posted26 Aug 2014 (estimated)
Study startApr 2014
Primary completionDec 2019
Study completionDec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02225392
Sponsor's protocol ID: NL45394.018.13
Other IDs: 5.2.13.064, 90713477
Acronym: TASMA
Status last verified: Dec 2022
First submitted: 30 Jul 2014
Last updated: 5 Dec 2022
Results posted: No
Data monitoring committee: Yes

Publications

Wijsman PC, van Smoorenburg LH, van den Elzen RM, Goorsenberg AWM, d'Hooghe JNS, Carpaij OA, Nawijn MC, Bloemen PR, van den Berk IAH, Galban CJ, Bell AJ, Weinheimer O, de Bruin DM, Annema JT, van den Berge M, Bonta PI. Detection of Airway Remodeling in Asthma Using Bronchoscopic Optical Coherence Tomography. CHEST Pulm. 2025 Feb 24;3(3):100143. doi: 10.1016/j.chpulm.2025.100143. eCollection 2025 Sep.
PubMed 42548535
Wijsman PC, Goorsenberg AWM, Keijzer N, d'Hooghe JNS, Ten Hacken NHT, Shah PL, Weersink EJM, de Brito JM, de Souza Xavier Costa N, Mauad T, Nawijn MC, Vonk JM, Annema JT, Burgess JK, Bonta PI. Airway wall extracellular matrix changes induced by bronchial thermoplasty in severe asthma. J Allergy Clin Immunol. 2024 Feb;153(2):435-446.e4. doi: 10.1016/j.jaci.2023.09.035. Epub 2023 Oct 5.
PubMed 37805024
Goorsenberg AWM, d'Hooghe JNS, Slats AM, van den Aardweg JG, Annema JT, Bonta PI. Resistance of the respiratory system measured with forced oscillation technique (FOT) correlates with bronchial thermoplasty response. Respir Res. 2020 Feb 12;21(1):52. doi: 10.1186/s12931-020-1313-6.
PubMed 32050956
d'Hooghe JNS, Ten Hacken NHT, Weersink EJM, Sterk PJ, Annema JT, Bonta PI. Emerging understanding of the mechanism of action of Bronchial Thermoplasty in asthma. Pharmacol Ther. 2018 Jan;181:101-107. doi: 10.1016/j.pharmthera.2017.07.015. Epub 2017 Jul 27.
PubMed 28757156

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma
ClinicalTrials.gov ID: NCT02225392
Acronym / sponsor ID: TASMA / NL45394.018.13
Conditions: Asthma, Bronchial Asthma
Keywords: Bronchial thermoplasty, Severe asthma
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, The Netherlands Asthma Foundation, Boston Scientific Corporation
Study start: Apr 2014
Primary completion: Dec 2019 (actual)
Study completion: Dec 2019 (actual)
First posted: 26 Aug 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.

Bronchial Thermoplasty (BT) is a novel, innovative device-based treatment of severe asthma that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy.

Hypothesis:

Detailed description

This study has a two-fold purpose:

to unravel the targets of BT in severe asthma (how does it work?) which is fundamental for better patient selection (who benefits most?) and further improvement of BT technology and novel asthma therapy development (how to treat better?). These objectives can only be achieved by linking patient-reported outcomes to airway structure/function, which is the principal aim of the study proposed.
to investigate clinical outcome analyses

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Delayed bronchial thermoplasty	Active comparator	Procedure: Bronchial thermoplasty, Device: Alair system (Boston Scientific, USA)After randomisation they will wait for 25 weeks (control group) and then start with bronchial thermoplasty. Bronchial thermoplasty (BT) will be performed using the Alair system (Boston Scientific, USA). Patients will undergo 3 bronchoscopy procedures with BT at least 3 weeks apart. Treatment sessions are designed to address different lobes of the lung with the right lower lobe treated during the first bronchoscopy, the left lower lobe treated during the second bronchoscopy, and both the right and left upper lobes treated in the third and final bronchoscopy. The right middle lobe and proximal airways including RC2 are left untreated.
Immediate bronchial thermoplasty	Experimental	Procedure: Bronchial thermoplasty, Device: Alair system (Boston Scientific, USA)After randomisation they start immediate with bronchial thermoplasty treatment. Bronchial thermoplasty (BT) will be performed using the Alair system (Boston Scientific, USA). Patients will undergo 3 bronchoscopy procedures with BT at least 3 weeks apart. Treatment sessions are designed to address different lobes of the lung with the right lower lobe treated during the first bronchoscopy, the left lower lobe treated during the second bronchoscopy, and both the right and left upper lobes treated in the third and final bronchoscopy. The right middle lobe and proximal airways including RC2 are left untreated.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Males or females age 18 or greater and 65 or less
The diagnosis of asthma confirmed by at least one of the following as assessed at least once during the past 5 years before the study:
Subject is taking regular maintenance medication (GINA step 4-5) for past 6 months that includes:
Per protocol bronchial hyper-responsiveness to methacholine (PC20<4 mg/ml)
Other asthma medications are acceptable (such as Leukotriene modifiers, Theophylline, Omalizumab treatment (or discontinuation for at least 6 months) Systemic corticosteroid use (≤20mg/day prednisone equivalent))

Key exclusion criteria (19 listed)

Asthma exacerbation during the prior 4 weeks.
Subject has 5 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for mechanical or endotracheal intubation for asthma in the previous year.
Respiratory tract infection within past 4 weeks
Subject has a known sensitivity to medications required to perform bronchoscopy
Subject is using immunosuppressant therapy other than oral steroid therapy

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 thermoplastyBronchial thermoplasty (BT) will be performed using the Alair system (Boston Scientific, USA). Patients will undergo 3 bronchoscopy procedures with BT at least 3 weeks apart. Treatment sessions are designed to address different lobes of the lung with the right lower lobe treated during the first bronchoscopy, the left lower lobe treated during the second bronchoscopy, and both the right and left upper lobes treated in the third and final bronchoscopy. The right middle lobe and proximal airways including RC2 are left untreated.	Procedure or surgery	Delayed bronchial thermoplasty, Immediate bronchial thermoplasty
Alair system (Boston Scientific, USA)The alair system consist of a controller and a bastket catheter.	Device	Delayed bronchial thermoplasty, Immediate bronchial thermoplasty

Primary outcome

The change in airway smooth muscle (ASM) mass between immediate BT treated and the control group (N=20, randomized)
Time frame: Baseline, week 25
The change in ASM mass as determined by the percentage of ASM surface area in airway biopsies between: * the immediate BT group and * the delayed BT group = control group

18 secondary outcomes

The change in ASM mass in airway biopsies before and after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Time frame: Baseline, 25 weeks
The change in structural airway remodelling after and during bronchial thermoplasty treatment
Time frame: Baseline, week 25
The change in pre-and post bronchodilator FEV1 and related % reversibility between immediate BT treated and control group (N=20, randomized)
Time frame: Baseline, 24 week
The change in PC20 methacholine between immediate BT treated and control group (N=20, randomized)
Time frame: Baseline, 24 week
The change in Fraction of exhaled nitric oxide (FeNO) between immediate BT treated and control group (N=20, randomized)
Time frame: Baseline, 24 week
The change in asthma control questionnaire (ACQ) between immediate BT treated and control group (N=20, randomized)
Time frame: Baseline, 24 week
The change in - asthma related quality of life questionnaire (AQLQ) between immediate BT treated and control group (N=20, randomized)
Time frame: Baseline, 24 week
The change in health care utilization between immediate BT treated and control group (N=20, randomized)
Time frame: Baseline, 24 week
The change in rescue medication use between immediate BT treated and control group (N=20, randomized)
Time frame: Baseline, 24 week
The change in inflammatory cell density/counts in biopsy, BAL and induced sputum between immediate BT treated and control group (N=20, randomized)
Time frame: Baseline, 25 week
The change in pre-and post bronchodilator FEV1 and related % reversibility after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Time frame: Baseline, 24 week
The change in PC20 methacholine after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Time frame: Baseline, 24 week
The change in Fraction of exhaled nitric oxide (FeNO) after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Time frame: Baseline, 24 week
The change in asthma control questionnaire (ACQ) after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Time frame: Baseline, 24 week
The change in asthma related quality of life questionnaire (AQLQ) after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Time frame: Baseline, 24 week
The change in health care utilization after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Time frame: Baseline, 24 week
The change in rescue medication use after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Time frame: Baseline, 24 week
The change in inflammatory cell density/counts in biopsy, BAL and induced sputum before and after bronchial thermoplasty treatment (N=40, observational, before and after BT)
Time frame: Baseline, 25 week

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 5 Dec 2022.
Derived from this study: PubMed 42548535Wijsman PC, van Smoorenburg LH, van den Elzen RM, Goorsenberg AWM, d'Hooghe JNS, Carpaij OA, Nawijn MC, Bloemen PR, van den Berk IAH, Galban CJ, Bell AJ, Weinheimer O, de Bruin DM, Annema JT, van den Berge M, Bonta PI. Detection of Airway Remodeling in Asthma Using Bronchoscopic Optical Coherence Tomography. CHEST Pulm. 2025 Feb 24;3(3):100143. doi: 10.1016/j.chpulm.2025.100143. eCollection 2025 Sep.
Derived from this study: PubMed 37805024Wijsman PC, Goorsenberg AWM, Keijzer N, d'Hooghe JNS, Ten Hacken NHT, Shah PL, Weersink EJM, de Brito JM, de Souza Xavier Costa N, Mauad T, Nawijn MC, Vonk JM, Annema JT, Burgess JK, Bonta PI. Airway wall extracellular matrix changes induced by bronchial thermoplasty in severe asthma. J Allergy Clin Immunol. 2024 Feb;153(2):435-446.e4. doi: 10.1016/j.jaci.2023.09.035. Epub 2023 Oct 5.
Derived from this study: PubMed 32050956Goorsenberg AWM, d'Hooghe JNS, Slats AM, van den Aardweg JG, Annema JT, Bonta PI. Resistance of the respiratory system measured with forced oscillation technique (FOT) correlates with bronchial thermoplasty response. Respir Res. 2020 Feb 12;21(1):52. doi: 10.1186/s12931-020-1313-6.
Derived from this study: PubMed 28757156d'Hooghe JNS, Ten Hacken NHT, Weersink EJM, Sterk PJ, Annema JT, Bonta PI. Emerging understanding of the mechanism of action of Bronchial Thermoplasty in asthma. Pharmacol Ther. 2018 Jan;181:101-107. doi: 10.1016/j.pharmthera.2017.07.015. Epub 2017 Jul 27.

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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.

Jouke T Annema, Prof. Dr. principal investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

P I Bonta, Dr principal investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 inclusion and 19 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 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands, United Kingdom. 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?

The change in airway smooth muscle (ASM) mass between immediate BT treated and the control group (N=20, randomized) (time frame: Baseline, week 25). 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 NCT02225392, which also lists 4 linked publications.

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 5 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.