Bronchial Thermoplasty Global Registry

Asthma Clinical Trial

— BTGR  

Official title:

Bronchial Thermoplasty (BT) Global Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104856
• Other study ID #: E7086
• Status: Completed
• Start date: January 2014
• Est. completion date: June 26, 2019

Study information

• Verified date: September 2019
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Alair System (Bronchial Thermoplasty)

Locations

Country	Name	City	State
Australia	Peninsula Health	Frankston	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Macquarie University Private Hospital	North Ryde	New South Wales
Czechia	Klinika Tuberkulozy a Respiracnich Onemocneni	Prague
Germany	Universitätsklinikum Bonn	Bonn
Germany	Ruhrlandklinik, Westdeutsches Lungenzentrum	Essen
Germany	Thoraxklinik, University of Heidelberg	Heidelberg
Germany	University Hospital of Regensburg	Regensburg
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti	Ancona
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	Aricispedale Santa Maria Nuova	Reggio Emilia
Netherlands	Academic Medical Center	Amsterdam
South Africa	University of Cape Town Groote Shuur Hospital	Cape Town
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Germans Trias I Puyol	Barcelona
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
United Kingdom	Gartnavel General Hospital	Glasgow	Scotland
United Kingdom	Wythenshawe Hospital University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Australia,  Czechia,  Germany,  Italy,  Netherlands,  South Africa,  Spain,  United Kingdom, 

Outcome

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