Bronchial Thermoplasty 10+ Year Study

Completed

• Conditions: Asthma

• Registration Number: NCT03243292
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-08
• Study Start: 2017-12-11
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.	The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.	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.
Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.	The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.	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.

Secondary Outcome Measures

Name	Time	Method
rates of emergency room visits for respiratory adverse events	One day visit	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:
Rates of Respiratory Serious Adverse Events (SAEs)	One day visit	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:
Proportion of subjects with hospitalizations for respiratory adverse events	One day visit	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	One day visit	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 year	One day visit	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:
Rates of hospitalizations for respiratory adverse events	One day visit	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 subject	One day visit	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:
proportion of subjects with emergency room visits for respiratory adverse events	One day visit	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:
Proportion of subjects with respiratory SAEs)	One day visit	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:

Trial Locations

Locations (17)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Regions Hospital Health Partners Specialty Center; 🇺🇸 Saint Paul, Minnesota, United States

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Pulmonary Associates of Northern Virginia; 🇺🇸 Arlington, Virginia, United States

Imandade Santa Casa de Misercordia; 🇧🇷 Pôrto Alegre, RS, Brazil

Faculdade da Medicina do ABC; 🇧🇷 Santo André, Sao Paulo, Brazil

Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides; 🇧🇷 Pôrto Alegre, Brazil

Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ; 🇧🇷 Rio De Janeiro, Brazil

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