To evaluate long term safety, efficacy and airway remodelling effects of BT in patients with severe asthma.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the health care utilization ( Emergency room visits,
Hospitalizations, Severe exacerbations rate) measured yearly over 5 years and
compared to the pre- and post BT-treatment.
Secondary outcome
Secondary endpoints are the following parameters measured over 5 years compared
to the parameters measured pre- and post-BT treatment:
1). Clinical outcome parameters, including ACQ/ AQLQ scores, health care
utilization ( Emergency room visits, Hospitalizations, Severe exacerbations
rate), medication, pulmonary function test (PC20 methacholine, pre- and post
bronchodilator FEV1 and FEV1 % revesibility, FeNO, Airway-resistance
(sRaw)/-conductance(sGaw)/-mechanics (forced oscillation technique (FOT))
Optional only for AMC / UMCG recruited patients:
2). ASM mass as determined by percentage/absolute ASM surface area and distance
of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies.
3). OCT determined changes in structural airway remodelling as measured by
changes in lumen area (Ai) and airway wall thickness (Aaw).
Background summary
Bronchial Thermoplasty (BT) is a device-based severe asthma treatment based on
local, radio-frequent energy delivery in the large airways that was developed
to prevent excessive bronchoconstriction by reducing airway smooth muscle
(ASM). The 5-year safety data of BT show a reduction in severe exacerbations,
hospitalizations and emergency department visits and improvement in asthma
symptoms in patients with severe asthma. Additional long term safety and
efficacy data in severe asthma patients treated with BT are needed.
Study objective
To evaluate long term safety, efficacy and airway remodelling effects of BT in
patients with severe asthma.
Study design
This will be an investigator-initiated multicenter, international prospective
observational extension study of severe asthma patients who have previously
been treated in the TASMA study, an investigator-initiated multicenter,
international randomized controlled trial.
Eligible patients enroll the extension study after the last visit in de TASMA
study, the 24th week following the last BT treatment.
The local doctor will be advised to wean of oral and inhaled steroids if
possible at their own discretion. After the last TASMA visit subjects are asked
to visit yearly to measure the pre-defined endpoints. Safety will be monitored
continuously throughout study participation. Efficacy assessments will we done
yearly beginning at 1 year following the last TASMA visit during which patients
undergo physical examination, questionnaires, pulmonary function test, health
care utilization assessment (number of severe asthma exacerbations, emergency
room visits and hospital admissions) and their medication use will be reported.
Next to this, patient recruited in the AMC and UMCG will be additionally asked
if they are willing to undergo 1 extra bronchoscopy procedure 2 years after the
end of the TASMA study to determine ASM mass in endobronchial biopsies and
changes in airway remodeling by OCT.
Study burden and risks
For this study there are no major risks involved. All the study procedures
except for the research bronchoscopy, FOT and the provocation test with
metacholine are standard asthma care. During these test the patient will be
fully monitored by qualified lung function technicians and a medical doctor
according to the hospital SOPs.
In our opinion the balance between risks and discomfort for the patients which
is expected to be low and the scientific insights that can be obtained is
acceptable.
The optional bronchoscopies will be performed under conscious sedation
(midazolam or propofol) to minimize patient discomfort. Previous experiences in
research bronchoscopies in severe asthma patients by our group and others have
proven these procedures to be safe. To our opinion the burden of the additional
bronchoscopies including endoscopic biopsies and OCT imaging is justified by
the scientific insights that can be obtained. The long term pathological
effects of BT on airway remodelling and ASM mass are unknown, and we believe
the current study design is the only way to determine these long-term effects.
Theoretically, this information could provide clues to optimize further this
relatively new treatment technique.
The benefit of study participation is that BT clinical outcome,
including safety and efficacy parameters will be monitored over a period of 5
years. The results of the study can contribute to improved patient selection
for BT and further optimize BT treatment and potentially improve BT technology.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
participation in the TASMA study
Exclusion criteria
participating in another clinical trial involving respiratory intervention which in the opinion of the investigator might interfere with the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02225392 |
| CCMO | NL53703.018.15 |