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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02104856




Registration number
NCT02104856
Ethics application status
Date submitted
2/04/2014
Date registered
4/04/2014
Date last updated
13/09/2019

Titles & IDs
Public title
Bronchial Thermoplasty Global Registry
Scientific title
Bronchial Thermoplasty (BT) Global Registry
Secondary ID [1] 0 0
E7086
Universal Trial Number (UTN)
Trial acronym
BTGR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Alair System (Bronchial Thermoplasty)

Alair System (Bronchial Thermoplasty) - Asthma patients undergoing Bronchial Thermoplasty treatment with commercially available Alair device as per Directions For Use.


Treatment: Devices: Alair System (Bronchial Thermoplasty)


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients who experience severe asthma exacerbations - The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Asthma Quality of Life Questionnaire (AQLQ) score - Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) scores will be summarized descriptively for Year 1 and Year 2 post-BT.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Asthma Control Test (ACT) score - Change from baseline in Asthma Control Test (ACT) scores will be summarized descriptively for Year 1 and Year 2 post-BT.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Emergency department visits for asthma symptoms - Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Hospitalizations for asthma symptoms - Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Unscheduled office visits including urgent care visits for asthma symptoms. - Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1) - Pre- and post-bronchodilator FEV1 will be summarized for Year 1 and Year 2 post-BT treatment (% predicted and absolute value). Change from baseline will also be summarized.
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Respiratory Adverse Events - Separated by treatment period and post-treatment period
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Lung Volumes - Collected at sites where it is standard of care
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Diffusion Capacity - Collected at sites where it is standard of care
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.) - Collect asthma maintenance medications at all sites
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
Patient satisfaction survey score - Two question survey collected at 12 month and 24 month annual visit
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold) - Collected at sites where it is standard of care
Timepoint [12] 0 0
2 years
Secondary outcome [13] 0 0
Sputum eosinophils - Collected at sites where it is standard of care
Timepoint [13] 0 0
2 years
Secondary outcome [14] 0 0
Exhaled nitric oxide (eNO) - Collected at sites where it is standard of care
Timepoint [14] 0 0
2 years
Secondary outcome [15] 0 0
Methacholine challenge (Methacholine PC20) - Collected at sites where it is standard of care
Timepoint [15] 0 0
2 years

Eligibility
Key inclusion criteria
1. Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment
according to the Alair System DFU.

2. Patient is able to read, understand, and sign a written Informed Consent to
participate in the Registry and able to comply with the registry requirements.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has any medical condition that would make them inappropriate for BT treatment,
in the Investigator's opinion.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University Private Hospital - North Ryde
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Peninsula Health - Frankston
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
4001 - Herston
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Prague
Country [2] 0 0
Germany
State/province [2] 0 0
Bonn
Country [3] 0 0
Germany
State/province [3] 0 0
Essen
Country [4] 0 0
Germany
State/province [4] 0 0
Heidelberg
Country [5] 0 0
Germany
State/province [5] 0 0
Regensburg
Country [6] 0 0
Italy
State/province [6] 0 0
Ancona
Country [7] 0 0
Italy
State/province [7] 0 0
Brescia
Country [8] 0 0
Italy
State/province [8] 0 0
Reggio Emilia
Country [9] 0 0
Netherlands
State/province [9] 0 0
Amsterdam
Country [10] 0 0
South Africa
State/province [10] 0 0
Cape Town
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Scotland
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this Registry is to collect real-world data on patients undergoing
bronchial thermoplasty (BT) treatment.
Trial website
https://clinicaltrials.gov/show/NCT02104856
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Niven, MD
Address 0 0
Wythenshawe Hospital - University of Manchester
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications