China Alair System Registry Study-CARE Study

• Conditions: Asthma
• Interventions: Device: Alair System

• Registration Number: NCT02206269
• Lead Sponsor: BSC International Medical Trading (Shanghai) Co., Ltd.

Brief Summary

The objective of this Registry is to collect real-world outcome data for bronchial thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic despite taking standard of care maintenance medications.

Detailed Description

Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and the anticipated reduction in healthcare utilization events and cost by way of a reduction in severe asthma exacerbations.

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Study Start: 2015-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

1. Patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications.
2. Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the study requirements.
3. Patient is able to undergo bronchoscopy in the opinion of the Investigator or per hospital guidelines and as described in the Alair System Directions for Use (DFU).

Exclusion Criteria

1. Patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
2. Patient has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alair System	Alair System	This is a single arm study with Alair system used.

Primary Outcome Measures

Name	Time	Method
Incidence of severe asthma exacerbations following BT with the Alair System.	1 year	Severe asthma exacerbation is defined as worsening of asthma symptoms requiring use of systemic corticosteroids (tablets, suspension, or injection) (NAEPP Guidelines, 2007).; For patients already taking oral corticosteroids on a daily or alternate day basis, a severe asthma exacerbation is defined as a worsening of asthma symptoms requiring any increase in daily dose of systemic corticosteroids.; For consistency, courses of corticosteroids separated by 1 week or more will be treated as separate severe exacerbations.

Secondary Outcome Measures

Name	Time	Method
Quarlity of life of Patients	1 year	Asthma Quality of Life Questionnaire (AQLQ) score Asthma Control Questionnaire(ACQ)
Health care utilization	1 year	Emergency Department Visits,Hospitalizations,Unscheduled office visits including urgent care visits
FEV1	1 year	Pre- and post-bronchodilator FEV1
Serious respiratory adverse events	1 year	Rates of and proportion of patients with serious respiratory adverse events

Trial Locations

Locations (1)

BSC International Medical Trading (Shanghai) Co., Ltd.; 🇨🇳 Shanghai, Shanghai, China