China Alair System Registry Study-CARE Study

NCT02206269 | Unknown

• 1 other identifier: E7100
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quarlity of life of Patients

  1 year

• Health care utilization

  1 year

• FEV1

  1 year

• Serious respiratory adverse events

  1 year

Study Arms (1)

Alair System

This is a single arm study with Alair system used.

Device: Alair System

Interventions

Alair System DEVICE

The Alair system is used for doing bronchial thermoplasty.

Alair System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The real world patient polulaiton who undergo BT in China

You may qualify if:

• Patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications.
• 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.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• BSC International Medical Trading (Shanghai) Co., Ltd.: lead

Study Sites (1)

BSC International Medical Trading (Shanghai) Co., Ltd.

Shanghai, Shanghai Municipality, 200023, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jiangtao Lin, Professor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: August 1, 2014
• Study Start: April 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

CN (1)