Bronchial Thermoplasty 10+ Year Study

Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Bronchial Thermoplasty

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.

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Brazil
  • Pôrto Alegre, Brazil, 90480-000
    • Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides
  • Rio De Janeiro, Brazil, 21949-900
    • Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ
  • RS
    • Pôrto Alegre, RS, Brazil, 90035074
      • Imandade Santa Casa de Misercordia
  • Sao Paulo
    • Santo André, Sao Paulo, Brazil, 09060-650
      • Faculdade da Medicina do ABC
• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • Montreal Chest Institute
    • Quebec City, Quebec, Canada, G1V4G5
      • Institute Universitaire de Cardiologie et Pneumologie de Quebec
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
• United Kingdom
  • Leicester, United Kingdom, LE5 4PW
    • University of Leicester Glenfield Hospital
  • Manchester, United Kingdom, M23 9LT
    • Wythenshawe Hospital, University of Manchester
  • London
    • Chelsea, London, United Kingdom, SW10 9NH
      • Chelsea and Westminster Hospital
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 OYN
      • Gartnavel General Hospital
• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Michigan
    • Detroit, Michigan, United States, 48202-268
      • Henry Ford Health System
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130
      • Regions Hospital Health Partners Specialty Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110-1093
      • Washington University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Pulmonary Associates of Northern Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated; Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2)	Other: Bronchial Thermoplasty; patients had radio frequency ablation of the smooth muscle for asthma
Control; Subjects that participated in prior study (AIR) or (RISA) but did not receive Bronchial Thermoplasty Treatment. Determine if the Control group of subjects asthma has progressed any different from those subjects treated with BT.	Other: Bronchial Thermoplasty; patients had radio frequency ablation of the smooth muscle for asthma
Sham; Subjects that participated in the AIR2 study, were blinded and did not receive the treatment. Determine if the Sham group of subjects asthma has progressed any different from those subjects treated with BT.	Other: Bronchial Thermoplasty; patients had radio frequency ablation of the smooth muscle for asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.	Following BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary Volumetric HRCT scan at the BT 10+study visit in those3 subjects who had baseline Volumetric HRCT scan in the AIR2 study. Baseline and 10+ year HRCTs are to be read by an independent radiologist and also assessed by an independent pulmonologist.	The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.	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.	The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe asthma exacerbation rates exacerbations	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:	One day visit
Severe asthma exacerbation rates subject	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:	One day visit
Severe asthma exacerbation rates year	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:	One day visit
rates of emergency room visits for respiratory adverse events	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:	One day visit
proportion of subjects with emergency room visits for respiratory adverse events	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:	One day visit
Rates of hospitalizations for respiratory adverse events	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:	One day visit
Proportion of subjects with hospitalizations for respiratory adverse events	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:	One day visit
Rates of Respiratory Serious Adverse Events (SAEs)	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:	One day visit
Proportion of subjects with respiratory SAEs)	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:	One day visit

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Thomas Bowman, MD, Medical Director, Boston Scientific

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): January 10, 2019

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Registry; Bronchial Thermoplasty; Alair
• Other Study ID Numbers: 92115848

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No