Bronchial Thermoplasty Global Registry

Boston Scientific Corporation158 enrolled

Overview

The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.

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.

Study Type

OBSERVATIONAL

Enrollment

158

Conditions

Asthma

Interventions

Alair System (Bronchial Thermoplasty)DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment according to the Alair System DFU. 2. 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. Exclusion Criteria: 1\. Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.

Locations (19)

Macquarie University Private Hospital

North Ryde, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Outcomes

Primary Outcomes

Proportion of patients who experience severe asthma exacerbations

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.

Time frame: 2 years

Secondary Outcomes

Asthma Quality of Life Questionnaire (AQLQ) score

Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) scores will be summarized descriptively for Year 1 and Year 2 post-BT.

Time frame: 2 years

Asthma Control Test (ACT) score

Change from baseline in Asthma Control Test (ACT) scores will be summarized descriptively for Year 1 and Year 2 post-BT.

Time frame: 2 years

Emergency department visits for asthma symptoms

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.

Time frame: 2 years

Hospitalizations for asthma symptoms

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.

Time frame: 2 years

Unscheduled office visits including urgent care visits for asthma symptoms.

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.

Time frame: 2 years

Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.