BTGR: Bronchial Thermoplasty Global Registry

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT02104856

Collaborator

(none)

158

Enrollment

Locations

65.8

Actual Duration (Months)

8.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

158 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

Bronchial Thermoplasty (BT) Global Registry

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jun 26, 2019

Actual Study Completion Date :

Jun 26, 2019

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

Proportion of patients who experience severe asthma exacerbations [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

Asthma Quality of Life Questionnaire (AQLQ) score [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.
Asthma Control Test (ACT) score [2 years]
Change from baseline in Asthma Control Test (ACT) scores will be summarized descriptively for Year 1 and Year 2 post-BT.
Emergency department visits for asthma symptoms [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.
Hospitalizations for asthma symptoms [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.
Unscheduled office visits including urgent care visits for asthma symptoms. [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.
Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1) [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.
Respiratory Adverse Events [2 years]
Separated by treatment period and post-treatment period
Lung Volumes [2 years]
Collected at sites where it is standard of care
Diffusion Capacity [2 years]
Collected at sites where it is standard of care
Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.) [2 years]
Collect asthma maintenance medications at all sites
Patient satisfaction survey score [2 years]
Two question survey collected at 12 month and 24 month annual visit
Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold) [2 years]
Collected at sites where it is standard of care
Sputum eosinophils [2 years]
Collected at sites where it is standard of care
Exhaled nitric oxide (eNO) [2 years]
Collected at sites where it is standard of care
Methacholine challenge (Methacholine PC20) [2 years]
Collected at sites where it is standard of care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment according to the Alair System DFU.
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Macquarie University Private Hospital	North Ryde	New South Wales	Australia	2109
2	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	4001
3	Peninsula Health	Frankston	Victoria	Australia	3199
4	Klinika Tuberkulozy a Respiracnich Onemocneni	Prague		Czechia	12802
5	Universitätsklinikum Bonn	Bonn		Germany	D-53105
6	Ruhrlandklinik, Westdeutsches Lungenzentrum	Essen		Germany	45239
7	Thoraxklinik, University of Heidelberg	Heidelberg		Germany	D-69126
8	University Hospital of Regensburg	Regensburg		Germany	93042
9	Azienda Ospedaliero Universitaria Ospedali Riuniti	Ancona		Italy	60126
10	Azienda Ospedaliera Spedali Civili di Brescia	Brescia		Italy	25123
11	Aricispedale Santa Maria Nuova	Reggio Emilia		Italy	41223
12	Academic Medical Center	Amsterdam		Netherlands	1105AZ
13	University of Cape Town Groote Shuur Hospital	Cape Town		South Africa	7925
14	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025
15	Hospital Germans Trias I Puyol	Barcelona		Spain	08916
16	Hospital General Universitario Gregorio Marañon	Madrid		Spain	28007
17	Hospital Universitario Fundacion Jimenez Diaz	Madrid		Spain	28040
18	Gartnavel General Hospital	Glasgow	Scotland	United Kingdom	G12 OYN
19	Wythenshawe Hospital University of Manchester	Manchester		United Kingdom	M23 9LT

Sponsors and Collaborators

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