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Bronchial Thermoplasty Global Registry (BTGR)

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ClinicalTrials.gov Identifier: NCT02104856
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.

Condition or disease Intervention/treatment
Asthma Device: Alair System (Bronchial Thermoplasty)

Detailed Description:

This Registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing BT treatment in the "real world" setting. Patients will be recruited at participating study centers that offer BT as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications.

The Registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. The treatment period is from the date of the first BT procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). The post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) BT procedure for 2-years of follow-up.

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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Study Type : Observational [Patient Registry]
Actual Enrollment : 158 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Bronchial Thermoplasty (BT) Global Registry
Actual Study Start Date : January 2014
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : June 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Alair System (Bronchial Thermoplasty)
Asthma patients undergoing Bronchial Thermoplasty treatment with commercially available Alair device as per Directions For Use.
Device: Alair System (Bronchial Thermoplasty)



Primary Outcome Measures :
  1. Proportion of patients who experience severe asthma exacerbations [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Asthma Quality of Life Questionnaire (AQLQ) score [ Time Frame: 2 years ]
    Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) scores will be summarized descriptively for Year 1 and Year 2 post-BT.

  2. Asthma Control Test (ACT) score [ Time Frame: 2 years ]
    Change from baseline in Asthma Control Test (ACT) scores will be summarized descriptively for Year 1 and Year 2 post-BT.

  3. Emergency department visits for asthma symptoms [ Time Frame: 2 years ]
    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.

  4. Hospitalizations for asthma symptoms [ Time Frame: 2 years ]
    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.

  5. Unscheduled office visits including urgent care visits for asthma symptoms. [ Time Frame: 2 years ]
    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.

  6. Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1) [ Time Frame: 2 years ]
    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.

  7. Respiratory Adverse Events [ Time Frame: 2 years ]
    Separated by treatment period and post-treatment period

  8. Lung Volumes [ Time Frame: 2 years ]
    Collected at sites where it is standard of care

  9. Diffusion Capacity [ Time Frame: 2 years ]
    Collected at sites where it is standard of care

  10. Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.) [ Time Frame: 2 years ]
    Collect asthma maintenance medications at all sites

  11. Patient satisfaction survey score [ Time Frame: 2 years ]
    Two question survey collected at 12 month and 24 month annual visit

  12. Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold) [ Time Frame: 2 years ]
    Collected at sites where it is standard of care

  13. Sputum eosinophils [ Time Frame: 2 years ]
    Collected at sites where it is standard of care

  14. Exhaled nitric oxide (eNO) [ Time Frame: 2 years ]
    Collected at sites where it is standard of care

  15. Methacholine challenge (Methacholine PC20) [ Time Frame: 2 years ]
    Collected at sites where it is standard of care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing BT according to labeled indications will be approached to participate in the Registry.
Criteria

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.

Exclusion Criteria:

1. Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104856


Locations
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Australia, New South Wales
Macquarie University Private Hospital
North Ryde, New South Wales, Australia, 2109
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4001
Australia, Victoria
Peninsula Health
Frankston, Victoria, Australia, 3199
Czechia
Klinika Tuberkulozy a Respiracnich Onemocneni
Prague, Czechia, 12802
Germany
Universitätsklinikum Bonn
Bonn, Germany, D-53105
Ruhrlandklinik, Westdeutsches Lungenzentrum
Essen, Germany, 45239
Thoraxklinik, University of Heidelberg
Heidelberg, Germany, D-69126
University Hospital of Regensburg
Regensburg, Germany, 93042
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona, Italy, 60126
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Aricispedale Santa Maria Nuova
Reggio Emilia, Italy, 41223
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
South Africa
University of Cape Town Groote Shuur Hospital
Cape Town, South Africa, 7925
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Germans Trias I Puyol
Barcelona, Spain, 08916
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
United Kingdom
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom, G12 OYN
Wythenshawe Hospital University of Manchester
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Robert Niven, MD Wythenshawe Hospital - University of Manchester
Principal Investigator: Alfons Torrego, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator: Felix Herth, MD Thoraxklinik, University of Heidelberg

Additional Information:

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02104856     History of Changes
Other Study ID Numbers: E7086
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Keywords provided by Boston Scientific Corporation:
Asthma
Bronchial Thermoplasty
Registry
Device
Alair
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases