China Alair System Registry Study-CARE Study

Asthma Clinical Trial

— CARE  

Official title:

Registry of Bronchial Thermoplasty (BT) Procedures in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02206269
• Other study ID #: E7100
• Status: Active, not recruiting
• Phase: N/A
• First received: July 24, 2014
• Last updated: February 22, 2018
• Start date: April 2015
• Est. completion date: June 2019

Study information

• Verified date: February 2018
• Source: BSC International Medical Trading (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Alair System
The Alair system is used for doing bronchial thermoplasty.

Locations

Country	Name	City	State
China	BSC International Medical Trading (Shanghai) Co., Ltd.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
BSC International Medical Trading (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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