Bronchial Thermoplasty Global Registry (BTGR)

Bronchial Thermoplasty (BT) Global Registry

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing BT according to labeled indications will be approached to participate in the Registry.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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.	2 years
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.	2 years
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.	2 years
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.	2 years
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.	2 years
Respiratory Adverse Events	Separated by treatment period and post-treatment period	2 years
Lung Volumes	Collected at sites where it is standard of care	2 years
Diffusion Capacity	Collected at sites where it is standard of care	2 years
Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.)	Collect asthma maintenance medications at all sites	2 years
Patient satisfaction survey score	Two question survey collected at 12 month and 24 month annual visit	2 years
Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold)	Collected at sites where it is standard of care	2 years
Sputum eosinophils	Collected at sites where it is standard of care	2 years
Exhaled nitric oxide (eNO)	Collected at sites where it is standard of care	2 years
Methacholine challenge (Methacholine PC20)	Collected at sites where it is standard of care	2 years

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: 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

Publications and helpful links

General Publications

• Torrego A, Herth FJ, Munoz-Fernandez AM, Puente L, Facciolongo N, Bicknell S, Novali M, Gasparini S, Bonifazi M, Dheda K, Andreo F, Votruba P, Langton D, Flandes J, Fielding D, Bonta PI, Skowasch D, Schulz C, Darwiche K, McMullen E, Grubb GM, Niven R. Bronchial Thermoplasty Global Registry (BTGR): 2-year results. BMJ Open. 2021 Dec 16;11(12):e053854. doi: 10.1136/bmjopen-2021-053854.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: April 2, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Asthma; Device; Registry; Bronchial Thermoplasty; Alair
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: E7086