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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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Scientific title
Bronchial Thermoplasty (BT) Global Registry
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Secondary ID [1]
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E7086
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Universal Trial Number (UTN)
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Trial acronym
BTGR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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)
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of patients who experience severe asthma exacerbations
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Asthma Quality of Life Questionnaire (AQLQ) score
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Assessment method [1]
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Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) scores will be summarized descriptively for Year 1 and Year 2 post-BT.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Asthma Control Test (ACT) score
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Assessment method [2]
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Change from baseline in Asthma Control Test (ACT) scores will be summarized descriptively for Year 1 and Year 2 post-BT.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Emergency department visits for asthma symptoms
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Assessment method [3]
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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.
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Hospitalizations for asthma symptoms
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Assessment method [4]
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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.
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Unscheduled office visits including urgent care visits for asthma symptoms.
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Assessment method [5]
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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.
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1)
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Assessment method [6]
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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.
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Respiratory Adverse Events
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Assessment method [7]
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Separated by treatment period and post-treatment period
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Timepoint [7]
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2 years
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Secondary outcome [8]
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Lung Volumes
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Assessment method [8]
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Collected at sites where it is standard of care
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Timepoint [8]
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2 years
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Secondary outcome [9]
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Diffusion Capacity
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Assessment method [9]
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Collected at sites where it is standard of care
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Timepoint [9]
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2 years
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Secondary outcome [10]
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Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.)
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Assessment method [10]
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Collect asthma maintenance medications at all sites
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Timepoint [10]
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2 years
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Secondary outcome [11]
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Patient satisfaction survey score
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Assessment method [11]
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Two question survey collected at 12 month and 24 month annual visit
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Timepoint [11]
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2 years
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Secondary outcome [12]
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Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold)
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Assessment method [12]
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Collected at sites where it is standard of care
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Timepoint [12]
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2 years
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Secondary outcome [13]
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Sputum eosinophils
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Assessment method [13]
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Collected at sites where it is standard of care
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Timepoint [13]
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2 years
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Secondary outcome [14]
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Exhaled nitric oxide (eNO)
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Assessment method [14]
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Collected at sites where it is standard of care
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Timepoint [14]
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2 years
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Secondary outcome [15]
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Methacholine challenge (Methacholine PC20)
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Assessment method [15]
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Collected at sites where it is standard of care
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Timepoint [15]
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2 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patient has any medical condition that would make them inappropriate for BT treatment,
in the Investigator's opinion.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/06/2019
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Sample size
Target
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Accrual to date
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Final
158
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Macquarie University Private Hospital - North Ryde
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [3]
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Peninsula Health - Frankston
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Recruitment postcode(s) [1]
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2109 - North Ryde
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Recruitment postcode(s) [2]
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4001 - Herston
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Recruitment postcode(s) [3]
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3199 - Frankston
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Recruitment outside Australia
Country [1]
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Czechia
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State/province [1]
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Prague
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Country [2]
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Germany
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State/province [2]
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Bonn
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Country [3]
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Germany
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State/province [3]
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Essen
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Country [4]
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Germany
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State/province [4]
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Heidelberg
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Country [5]
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Germany
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State/province [5]
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Regensburg
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Country [6]
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Italy
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State/province [6]
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Ancona
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Country [7]
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Italy
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State/province [7]
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Brescia
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Country [8]
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Italy
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State/province [8]
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Reggio Emilia
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Country [9]
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Netherlands
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State/province [9]
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Amsterdam
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Country [10]
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South Africa
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State/province [10]
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Cape Town
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Country [11]
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Spain
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State/province [11]
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Barcelona
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Country [12]
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Spain
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State/province [12]
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Madrid
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Country [13]
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United Kingdom
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State/province [13]
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Scotland
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Country [14]
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United Kingdom
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State/province [14]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boston Scientific Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this Registry is to collect real-world data on patients undergoing
bronchial thermoplasty (BT) treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02104856
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert Niven, MD
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Address
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Wythenshawe Hospital - University of Manchester
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02104856
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