Bronchial Thermoplasty Global Registry
- Conditions
- Asthma
- Interventions
- Device: Alair System (Bronchial Thermoplasty)
- Registration Number
- NCT02104856
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.
- Detailed Description
This Registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing BT treatment in the "real world" setting. Patients will be recruited at participating study centers that offer BT as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications.
The Registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. The treatment period is from the date of the first BT procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). The post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) BT procedure for 2-years of follow-up.
The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment according to the Alair System DFU.
- Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the registry requirements.
- Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alair System (Bronchial Thermoplasty) Alair System (Bronchial Thermoplasty) Asthma patients undergoing Bronchial Thermoplasty treatment with commercially available Alair device as per Directions For Use.
- Primary Outcome Measures
Name Time Method Proportion of patients who experience severe asthma exacerbations 2 years The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
- Secondary Outcome Measures
Name Time Method Sputum eosinophils 2 years Collected at sites where it is standard of care
Unscheduled office visits including urgent care visits for asthma symptoms. 2 years Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.
Lung Volumes 2 years Collected at sites where it is standard of care
Diffusion Capacity 2 years Collected at sites where it is standard of care
Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.) 2 years Collect asthma maintenance medications at all sites
Patient satisfaction survey score 2 years Two question survey collected at 12 month and 24 month annual visit
Exhaled nitric oxide (eNO) 2 years Collected at sites where it is standard of care
Asthma Control Test (ACT) score 2 years Change from baseline in Asthma Control Test (ACT) scores will be summarized descriptively for Year 1 and Year 2 post-BT.
Emergency department visits for asthma symptoms 2 years Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.
Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1) 2 years Pre- and post-bronchodilator FEV1 will be summarized for Year 1 and Year 2 post-BT treatment (% predicted and absolute value). Change from baseline will also be summarized.
Respiratory Adverse Events 2 years Separated by treatment period and post-treatment period
Asthma Quality of Life Questionnaire (AQLQ) score 2 years Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) scores will be summarized descriptively for Year 1 and Year 2 post-BT.
Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold) 2 years Collected at sites where it is standard of care
Methacholine challenge (Methacholine PC20) 2 years Collected at sites where it is standard of care
Hospitalizations for asthma symptoms 2 years Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.
Trial Locations
- Locations (19)
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Macquarie University Private Hospital
🇦🇺North Ryde, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Peninsula Health
🇦🇺Frankston, Victoria, Australia
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum
🇩🇪Essen, Germany
Thoraxklinik, University of Heidelberg
🇩🇪Heidelberg, Germany
University Hospital of Regensburg
🇩🇪Regensburg, Germany
Azienda Ospedaliero Universitaria Ospedali Riuniti
🇮🇹Ancona, Italy
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
Aricispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
University of Cape Town Groote Shuur Hospital
🇿🇦Cape Town, South Africa
Hospital Germans Trias I Puyol
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Wythenshawe Hospital University of Manchester
🇬🇧Manchester, United Kingdom
Klinika Tuberkulozy a Respiracnich Onemocneni
🇨🇿Prague, Czechia
Gartnavel General Hospital
🇬🇧Glasgow, Scotland, United Kingdom