Bronchial Thermoplasty Global Registry

NCT02104856 | Completed DMC

• 1 other identifier: E7086
• Study Type: observational
• Target: 158
• Locations: 8 countries
• Sites: 19

Brief Summary

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

Conditions

Asthma

Keywords

Asthma; Bronchial Thermoplasty; Registry; Device; Alair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Asthma Quality of Life Questionnaire (AQLQ) score

  2 years

• Asthma Control Test (ACT) score

  2 years

• Emergency department visits for asthma symptoms

  2 years

• Hospitalizations for asthma symptoms

  2 years

• Unscheduled office visits including urgent care visits for asthma symptoms.

  2 years

Study Arms (1)

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)

Interventions

Alair System (Bronchial Thermoplasty) DEVICE

Alair System (Bronchial Thermoplasty)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (19)

Macquarie University Private Hospital

North Ryde, New South Wales, 2109, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4001, Australia

Location

Peninsula Health

Frankston, Victoria, 3199, Australia

Location

Klinika Tuberkulozy a Respiracnich Onemocneni

Prague, 12802, Czechia

Location

Universitätsklinikum Bonn

Bonn, D-53105, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum

Essen, 45239, Germany

Location

Thoraxklinik, University of Heidelberg

Heidelberg, D-69126, Germany

Location

University Hospital of Regensburg

Regensburg, 93042, Germany

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti

Ancona, 60126, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Aricispedale Santa Maria Nuova

Reggio Emilia, 41223, Italy

Location

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

University of Cape Town Groote Shuur Hospital

Cape Town, 7925, South Africa

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Germans Trias I Puyol

Barcelona, 08916, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Gartnavel General Hospital

Glasgow, Scotland, G12 OYN, United Kingdom

Location

Wythenshawe Hospital University of Manchester

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34916324 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Bronchial Thermoplasty

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Catheter Ablation; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 4, 2014
• Study Start: January 1, 2014
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

ES (4); CZ (1); IT (3); ZA (1); AU (3); NL (1); DE (4); GB (2)