To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.No…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
SAFETY:
Absence of clinically significant post-treatment respiratory changes, following
BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary
HRCT scan at the BT 10+ study visit in those subjects who had a baseline HRCT
scan in the AIR2 Study.
EFFECTIVENESS:
Durability of the treatment effect by comparing the proportion of subjects who
experience severe asthma exacerbations during the first and fifth years after
BT treatment with the proportion of subjects who experience severe asthma
exacerbations during the 12 month period prior to the BT 10+ study visit.
Secondary outcome
The following additional endpoints will be evaluated for the 12 month period
prior to the BT 10+ study visit and will be compared to the first and fifth
years after BT treatment:
* Severe asthma exacerbation rates (exacerbations / subject / year)
* Emergency room visits for respiratory adverse events (rates of emergency room
visits and proportion of subjects with emergency room visits for respiratory
adverse events)
* Hospitalizations for respiratory adverse events (rates of hospitalizations
and proportion of subjects with hospitalizations for respiratory adverse events)
* Respiratory Serious Adverse Events (SAEs) (rates of respiratory SAEs, and
proportion of subjects with respiratory SAEs)
Background summary
The AlairTM Bronchial Thermoplasty System was developed as a novel system
designed to deliver radiofrequency energy to the airways of asthmatic patients.
Bronchial thermoplasty (BT) is a non-pharmacologic, bronchoscopic treatment for
subjects 18 years and older with severe persistent asthma that is not well
controlled with inhaled corticosteroids (ICS) and long-acting beta-agonists
(LABA). During the BT procedure, radiofrequency energy is used to heat the
airway walls in a controlled manner. The mechanism of action is, in part, a
lasting reduction in Airway Smooth Musle mass due to the heat produced during
the procedure. The reduction in Airway Smooth Musle was associated with the
clinical improvement seen in patients undergoing BT. The BT 10+ study will be
the first look at BT subjects beyond 5 years. The evaluation of baseline HRCT
scans from the BT subjects from the AIR2 study and comparison to the 10 year
follow-up HRCT scan will provide objective safety data to determine if
significant post-treatment changes exist.
Study objective
To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at
10 years follow-up or beyond in subjects previously enrolled in any of the
following Boston Scientific-sponsored, controlled pre-approval studies: AIR,
RISA and AIR2.
No formal hypothesis will be tested. Data will be summarized descriptively with
confidence intervals, as appropriate.
Study design
BT 10+ is an international multi-center, prospective follow-up study on
subjects who were previously enrolled in any of the following studies: AIR,
RISA and AIR2 trials. Subjects who received active BT treatment in any of the 3
trials will be eligible to participate upon achieving a minimum of at least 10
years* time from their last BT treatment*s 6-week follow-up.
Study burden and risks
The only new risks with the trial are those associated with HRCT scans and
pulmonary function testing. It is an observational study, patients will visit
the hospital once for ± 3 hours.
Boston Scientific Way 100
Marlborough MA 01752
US
Boston Scientific Way 100
Marlborough MA 01752
US
Listed location countries
Age
Inclusion criteria
- Previously enrolled in AIR, RISA or AIR2
- Subjects who received active BT treatment and had last BT treatment at least 10 years follow-up
- Control/Sham subjects with at least 10 years of long-term follow-up
Exclusion criteria
Severe asthma exacerbation or chest infection in the past 4 weeks
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 | NCT03243292 |
| CCMO | NL63770.042.17 |