Bronchial Thermoplasty 10+ Year Study

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243292
• Other study ID #: 92115848
• Status: Completed
• Start date: December 11, 2017
• Est. completion date: January 10, 2019

Study information

• Verified date: July 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Bronchial Thermoplasty
patients had radio frequency ablation of the smooth muscle for asthma

Locations

Country	Name	City	State
Brazil	Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides	Pôrto Alegre
Brazil	Imandade Santa Casa de Misercordia	Pôrto Alegre	RS
Brazil	Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ	Rio De Janeiro
Brazil	Faculdade da Medicina do ABC	Santo André	Sao Paulo
Canada	Montreal Chest Institute	Montréal	Quebec
Canada	Institute Universitaire de Cardiologie et Pneumologie de Quebec	Quebec City	Quebec
Netherlands	Universitair Medisch Centrum Groningen	Groningen
United Kingdom	Chelsea and Westminster Hospital	Chelsea	London
United Kingdom	Gartnavel General Hospital	Glasgow	Scotland
United Kingdom	University of Leicester Glenfield Hospital	Leicester
United Kingdom	Wythenshawe Hospital, University of Manchester	Manchester
United States	Pulmonary Associates of Northern Virginia	Arlington	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Southern California	Los Angeles	California
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Regions Hospital Health Partners Specialty Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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