China Alair System Registry Study-CARE Study (CARE)

Registry of Bronchial Thermoplasty (BT) Procedures in China

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Device: Alair System

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 Type: Observational
• Enrollment (Anticipated): 225

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200023
      • BSC International Medical Trading (Shanghai) Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The real world patient polulaiton who undergo BT in China

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alair System; This is a single arm study with Alair system used.	Device: Alair System; The Alair system is used for doing bronchial thermoplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe asthma exacerbations following BT with the Alair System.	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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BSC International Medical Trading (Shanghai) Co., Ltd.
• Investigators: Principal Investigator: Jiangtao Lin, Professor, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: E7100