Bronchial Thermoplasty Study: an observational study examining airway remodelling and repair in patients with severe persistent asthma treated with bronchial thermoplasty

Not Applicable

Completed

• Conditions: Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory; Respiratory; Asthma

• Registration Number: ISRCTN94263922
• Lead Sponsor: niversity of Leicester (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-16
• Study Completion: 2016-01-29
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed
2. Males and females of any race who are over the age of 18 years at the time informed the consent is obtained
3. Physician diagnosis of asthma, as per Global Initiative for Asthma (GINA) guidelines and currently prescribed inhaled corticosteroid (ICS) or inhaled corticosteroid-long-acting beta agonist (ICS-LABA) therapy GINA step 3 to step 5 asthma therapies
4. Patients assigned by the clinical team to receive bronchial thermoplasty as part of their asthma treatment plan

Exclusion Criteria

1. Patients who are considered unsuitable for inclusion by the assessing physician due to serious co-morbidities such as cancer, emphysema or significant bronchiectasis
2. Recent (within 4 weeks of visit 1) or current lower respiratory tract infection
3. A positive hepatitis B surface antigen or hepatitis C virus antibody, as determined by medical history and/or subject?s verbal report
4. A positive human immunodeficiency virus test or is taking anti-retroviral medications, as determined by medical history and/or subject?s verbal report
Additional exclusion criteria for patients who have agreed to take part in the MR Imaging part of the study
4.1. Patients with a contra-indication to MRI scanning: i.e. patients who are non MRI compatible (ferro-magnetic metallic implants, pacemakers) as per the MRI questionnaire
4.2. Patients with potential adverse reactions to Gd-DTPA intravascular MRI contrast agent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in immunopathological features following thermoplasty; Timepoint(s): Before thermoplasty, 3 weeks post thermoplasty and 6 weeks post thermoplasty

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures