China Alair System Registry Study-CARE Study

ID: NCT02206269
Status: Active, not recruiting
Phase: N/A
Start Date: April 01, 2015
First Submitted: July 24, 2014
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: BSC International Medical Trading (Shanghai) Co., Ltd.
Location: China
Conditions: Asthma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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.
Condition or disease Intervention/treatment Phase

Asthma

Device: Alair System
Other Names
N/A

Tracking Information

First Submitted DateJuly 24, 2014
Last Update Posted DateFebruary 22, 2018
Actual Start DateApril 01, 2015
Anticipated Completion DateJune 01, 2019
Actual Primary Completion DateDecember 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Incidence of severe asthma exacerbations following BT with the Alair System. [Time Frame: 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Quarlity of life of Patients [Time Frame: 1 year]

    Asthma Quality of Life Questionnaire (AQLQ) score Asthma Control Questionnaire(ACQ)

  • Health care utilization [Time Frame: 1 year]

    Emergency Department Visits,Hospitalizations,Unscheduled office visits including urgent care visits

  • FEV1 [Time Frame: 1 year]

    Pre- and post-bronchodilator FEV1

  • Serious respiratory adverse events [Time Frame: 1 year]

    Rates of and proportion of patients with serious respiratory adverse events

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleChina Alair System Registry Study-CARE Study
Official TitleRegistry of Bronchial Thermoplasty (BT) Procedures in China
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 TypeObservational [Patient Registry]
Study PhaseN/A
Estimated Enrollment
225
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Asthma
Target Follow-Up Duration 1 Year
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationThe real world patient polulaiton who undergo BT in China
Intervention
Device: Alair System

The Alair system is used for doing bronchial thermoplasty.

Other Names
Study Groups/Cohorts
Alair System
This is a single arm study with Alair system used.

Study Arms
Alair System
This is a single arm study with Alair system used.
Device : Alair System
The Alair system is used for doing bronchial thermoplasty.

Arm Intervention/Treatment
Alair System
This is a single arm study with Alair system used.
Device : Alair System

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment225
Completion DateJune 01, 2019
Eligibility Criteria: 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
China

Administrative Information

NCT Number:NCT02206269
Other Study ID Numbers
E7100
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
BSC International Medical Trading (Shanghai) Co., Ltd.
Collaborators
Not Available
Investigators
Principal Investigator
Jiangtao Lin, Professor
China-Japan Friendship Hospital