Asthma Clinical Trial
Official title:
Bronchial Thermoplasty (BT) Global Registry
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.
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