Severe AsthmaNCT02975284
Unraveling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma (TASMA) Extension Study
An observational study of Severe Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This study evaluates the longterm clinical outcomes, including safety and efficacy parameters after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Asthma
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to Sep 2024
- 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: All subjects who underwent BT treatment in the TASMA study (protocol No.NL45394.018.13) and were not lost to follow-up at the end of the 30 week pre-marked visit, and those willing to comply with the study protocol and routine visits for the duration of the study will be included. The expected number of patients included in the TASMA study is n=40. These are patients with severe asthma despite maximal asthma therapy.
Who may be able to join
- Subject participation in the TASMA study
- Ability and willingness to provide informed consent.
- Ability to comply with the study protocol
Who cannot join
- Subject participating in another clinical trial involving respiratory intervention which in the opinion of the investigator might interfere with the study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum
Amsterdam, North Holland, 1105 AZ
About this study
Official title: TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe
This study evaluates the longterm clinical outcomes, including safety and efficacy parameters after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension study.
- Conditions
- Severe Asthma
- Keywords
- bronchial thermoplasty, long term, interventional bronchoscopy
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe exacerbations rate
exacerbations / subject / year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Measured: measured yearly over 5 years
Emergency room visit for respiratory symptoms rate
emergency room visits for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Measured: measured yearly over 5 years
Hospitalization for respiratory symptoms rate
hospitalizations for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Measured: measured yearly over 5 years
Secondary outcomes (13)
Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
provocative concentration causing a 20% fall (PC20 ) methacholine test
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
Fractional exhaled nitric oxide (FeNO)
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
Airway-resistance (sRaw) mechanics
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
Airway-conductance(sGaw) mechanics
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
forced oscillation technique (FOT)
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured over 5 years
Asthma Control Questionnaire (ACQ) scores
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
Asthma Quality of Life Questionnaire (AQLQ) scores
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
Maintenance dose of oral steroids
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
Maintenance dose of inhaled steroids
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
Rescue medication use
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Measured: measured yearly over 5 years
Airway smooth muscle (ASM) mass
ASM mass as determined by percentage/absolute ASM surface area and distance of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies
Measured: 2 years after inclusion, 2,5 years after BT
optical coherence tomography (OCT) determined changes
OCT determined changes in structural airway remodelling as measured by changes in lumen area (Ai) and airway wall thickness (Aaw).
Measured: 2 years after inclusion, 2,5 years after BT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startAug 2015
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Principal investigator, Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Peter Bonta, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975284
- Sponsor's protocol ID
- NL53703.018.15
- Status last verified
- Jul 2019
- First submitted
- 21 Nov 2016
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe
- ClinicalTrials.gov ID
- NCT02975284
- Acronym / sponsor ID
- NL53703.018.15
- Conditions
- Severe Asthma
- Keywords
- bronchial thermoplasty, long term, interventional bronchoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- Aug 2015
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 29 Nov 2016 (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.
This study evaluates the longterm clinical outcomes, including safety and efficacy parameters after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who underwent BT treatment in the TASMA study (protocol No.NL45394.018.13) and were not lost to follow-up at the end of the 30 week pre-marked visit, and those willing to comply with the study protocol and routine visits for the duration of the study will be included. The expected number of patients included in the TASMA study is n=40. These are patients with severe asthma despite maximal asthma therapy.
Key inclusion criteria (3 listed)
- Subject participation in the TASMA study
- Ability and willingness to provide informed consent.
- Ability to comply with the study protocol
Key exclusion criteria (1 listed)
- Subject participating in another clinical trial involving respiratory intervention which in the opinion of the investigator might interfere with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severe exacerbations rate
Time frame: measured yearly over 5 years
exacerbations / subject / year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Emergency room visit for respiratory symptoms rate
Time frame: measured yearly over 5 years
emergency room visits for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Hospitalization for respiratory symptoms rate
Time frame: measured yearly over 5 years
hospitalizations for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
13 secondary outcomes
Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility
Time frame: measured yearly over 5 years
provocative concentration causing a 20% fall (PC20 ) methacholine test
Time frame: measured yearly over 5 years
Fractional exhaled nitric oxide (FeNO)
Time frame: measured yearly over 5 years
Airway-resistance (sRaw) mechanics
Time frame: measured yearly over 5 years
Airway-conductance(sGaw) mechanics
Time frame: measured yearly over 5 years
forced oscillation technique (FOT)
Time frame: measured over 5 years
Asthma Control Questionnaire (ACQ) scores
Time frame: measured yearly over 5 years
Asthma Quality of Life Questionnaire (AQLQ) scores
Time frame: measured yearly over 5 years
Maintenance dose of oral steroids
Time frame: measured yearly over 5 years
Maintenance dose of inhaled steroids
Time frame: measured yearly over 5 years
Rescue medication use
Time frame: measured yearly over 5 years
Airway smooth muscle (ASM) mass
Time frame: 2 years after inclusion, 2,5 years after BT
optical coherence tomography (OCT) determined changes
Time frame: 2 years after inclusion, 2,5 years after BT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Peter Bonta, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Jul 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 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?
Results are not available in the source record.
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?
Severe exacerbations rate (time frame: measured yearly over 5 years). The study lists 3 primary outcomes in all. 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 5 Jul 2019.