AsthmaCARENCT02206269
China Alair System Registry Study-CARE Study
An observational study of Asthma, run by BSC International Medical Trading (Shanghai) Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Alair System
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Jun 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The real world patient polulaiton who undergo BT in China
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
BSC International Medical Trading (Shanghai) Co., Ltd.
Shanghai, Shanghai Municipality, 200023
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Alair System
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alair SystemDevice
The Alair system is used for doing bronchial thermoplasty.
| Study group | Role | What they receive |
|---|---|---|
| Alair System | This is a single arm study with Alair system used. Receives: Device: Alair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Quarlity of life of Patients
Asthma Quality of Life Questionnaire (AQLQ) score Asthma Control Questionnaire(ACQ)
Measured: 1 year
Health care utilization
Emergency Department Visits,Hospitalizations,Unscheduled office visits including urgent care visits
Measured: 1 year
FEV1
Pre- and post-bronchodilator FEV1
Measured: 1 year
Serious respiratory adverse events
Rates of and proportion of patients with serious respiratory adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- BSC International Medical Trading (Shanghai) Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiangtao Lin, Professor, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206269
- Sponsor's protocol ID
- E7100
- Acronym
- CARE
- Status last verified
- Feb 2018
- First submitted
- 24 Jul 2014
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Bronchial Thermoplasty (BT) Procedures in China
- ClinicalTrials.gov ID
- NCT02206269
- Acronym / sponsor ID
- CARE / E7100
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- BSC International Medical Trading (Shanghai) Co., Ltd.University, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alair System | – | Device: Alair SystemThis is a single arm study with Alair system used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The real world patient polulaiton who undergo BT in China
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alair SystemThe Alair system is used for doing bronchial thermoplasty. | Device | Alair System |
Primary outcome
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.
4 secondary outcomes
Quarlity of life of Patients
Time frame: 1 year
Health care utilization
Time frame: 1 year
FEV1
Time frame: 1 year
Serious respiratory adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiangtao Lin, Professor principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by BSC International Medical Trading (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe asthma exacerbations following BT with the Alair System. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.