Clinical trial NCT03243292: Bronchial Thermoplasty 10+ Year Study
Official title: Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Bronchial Thermoplasty
Alair
Registry
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that participated in one one or more of the prior studies (AIR, RISA, or AIR2) will be invited to participate in this study.

Brief summary: 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.

Detailed description: Compare rates of severe asthma exacerbations of subjects during the first and fifth year after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 months period prior to enrollment.

Compare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to examine if there are any clinically significant post-treatment respiratory changes following BT defined as bronchiectasis or bronchial stenosis.

Eligibility criteria: Inclusion Criteria

* Subjects previously enrolled in AIR, RISA or AIR2
* Subjects who received active BT treatment and had last BT treatment at least 10 years and 6 weeks prior to enrollment
* Control/Sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks
* Subject is able to read, understand and sign a written Informed Consent to participate in the Study and able to comply with the study requirements

Exclusion Criteria:

* Severe asthma exacerbation or chest infection in the past 4 weeks. Subject entry into this study should be delayed until free from severe asthma exacerbation or chest infection for a minimum of 4 weeks.

Primary outcomes:
measure: Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.
timeFrame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
measure: Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.
timeFrame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Secondary outcomes:
measure: Severe asthma exacerbation rates exacerbations
timeFrame: One day visit
measure: Severe asthma exacerbation rates subject
timeFrame: One day visit
measure: Severe asthma exacerbation rates year
timeFrame: One day visit
measure: rates of emergency room visits for respiratory adverse events
timeFrame: One day visit
measure: proportion of subjects with emergency room visits for respiratory adverse events
timeFrame: One day visit
measure: Rates of hospitalizations for respiratory adverse events
timeFrame: One day visit
measure: Proportion of subjects with hospitalizations for respiratory adverse events
timeFrame: One day visit
measure: Rates of Respiratory Serious Adverse Events (SAEs)
timeFrame: One day visit
measure: Proportion of subjects with respiratory SAEs)
timeFrame: One day visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Paul
country: United States
facility: Regions Hospital Health Partners Specialty Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Arlington
country: United States
facility: Pulmonary Associates of Northern Virginia
state: Virginia
city: Pôrto Alegre
country: Brazil
facility: Imandade Santa Casa de Misercordia
state: RS
city: Santo André
country: Brazil
facility: Faculdade da Medicina do ABC
state: Sao Paulo
city: Pôrto Alegre
country: Brazil
facility: Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides
city: Rio De Janeiro
country: Brazil
facility: Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ
city: Montréal
country: Canada
facility: Montreal Chest Institute
state: Quebec
city: Quebec City
country: Canada
facility: Institute Universitaire de Cardiologie et Pneumologie de Quebec
state: Quebec
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Chelsea
country: United Kingdom
facility: Chelsea and Westminster Hospital
state: London
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
state: Scotland
city: Leicester
country: United Kingdom
facility: University of Leicester Glenfield Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital, University of Manchester
Study officials:
affiliation: Medical Director, Boston Scientific
name: Thomas Bowman, MD
role: STUDY_DIRECTOR
References:
citation: Chaudhuri R, Rubin A, Sumino K, Lapa E Silva JR, Niven R, Siddiqui S, Klooster K, McEvoy C, Shah PL, Simoff M, Khatri S, Barbers R, Mark Grubb G, McMullen EA, Olson JL, Laviolette M; BT10+ Study Group. Safety and effectiveness of bronchial thermoplasty after 10 years in patients with persistent asthma (BT10+): a follow-up of three randomised controlled trials. Lancet Respir Med. 2021 May;9(5):457-466. doi: 10.1016/S2213-2600(20)30408-2. Epub 2021 Jan 29.