Clinical trial NCT02104856: Bronchial Thermoplasty Global Registry
Official title: Bronchial Thermoplasty (BT) Global Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Bronchial Thermoplasty
Registry
Device
Alair
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing BT according to labeled indications will be approached to participate in the Registry.

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

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients who experience severe asthma exacerbations
timeFrame: 2 years
Secondary outcomes:
measure: Asthma Quality of Life Questionnaire (AQLQ) score
timeFrame: 2 years
measure: Asthma Control Test (ACT) score
timeFrame: 2 years
measure: Emergency department visits for asthma symptoms
timeFrame: 2 years
measure: Hospitalizations for asthma symptoms
timeFrame: 2 years
measure: Unscheduled office visits including urgent care visits for asthma symptoms.
timeFrame: 2 years
measure: Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1)
timeFrame: 2 years
measure: Respiratory Adverse Events
timeFrame: 2 years
measure: Lung Volumes
timeFrame: 2 years
measure: Diffusion Capacity
timeFrame: 2 years
measure: Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.)
timeFrame: 2 years
measure: Patient satisfaction survey score
timeFrame: 2 years
measure: Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold)
timeFrame: 2 years
measure: Sputum eosinophils
timeFrame: 2 years
measure: Exhaled nitric oxide (eNO)
timeFrame: 2 years
measure: Methacholine challenge (Methacholine PC20)
timeFrame: 2 years
Other outcomes:
Locations:
city: North Ryde
country: Australia
facility: Macquarie University Private Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Frankston
country: Australia
facility: Peninsula Health
state: Victoria
city: Prague
country: Czechia
facility: Klinika Tuberkulozy a Respiracnich Onemocneni
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum
city: Heidelberg
country: Germany
facility: Thoraxklinik, University of Heidelberg
city: Regensburg
country: Germany
facility: University Hospital of Regensburg
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Reggio Emilia
country: Italy
facility: Aricispedale Santa Maria Nuova
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Cape Town
country: South Africa
facility: University of Cape Town Groote Shuur Hospital
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Germans Trias I Puyol
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
state: Scotland
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital University of Manchester
Study officials:
affiliation: Wythenshawe Hospital - University of Manchester
name: Robert Niven, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Alfons Torrego, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thoraxklinik University of Heidelberg
name: Felix Herth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.