Bronchial Thermoplasty 10+ Year Study

Completed · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT03243292

Run by

Boston Scientific Corporation

People needed

192

Starts

2017-12-11

Expected to finish

2019-01-10

Last updated by the study team

2020-07-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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 — St 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, Rio Grande do Sul, Brazil
• Faculdade da Medicina do ABC — Santo André, São 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
• Montreal Chest Institute — Montreal, Quebec, Canada
• Institute Universitaire de Cardiologie et Pneumologie de Quebec — Québec, Quebec, Canada
• Universitair Medisch Centrum Groningen — Groningen, Netherlands
• 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 Kingdom

Full record on ClinicalTrials.gov

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