The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations. This will be a single center randomized and controlled study. Thirty subjects with severe asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic corticosteroids \>3 days each in the previous year) will be randomized 1:1 to either the thermoplasty group (bronchial thermoplasty and medical management) or control group (medical management only).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
RECRUITINGSevere exacerbation rate (change from baseline)
A severe exacerbation is defined by a burst of systemic corticosteroids \>3 days
Time frame: Baseline, 6 months and 12 months after the last thermoplasty procedure
Time to the first severe asthma exacerbation
Time frame: anytime
Mean oral glucocorticosteroid dose (mg equivalent prednisone)
Time frame: Baseline, 6 and 12 Months
Mild exacerbation rate
Time frame: Baseline, 6 and 12 Months
Pre- and post-bronchodilator FEV1
Time frame: Baseline, 6 and 12 Months
Asthma Control Questionnaire (ACQ) Score
Time frame: Baseline, 3, 6, 9 and 12 Months
Asthma Quality of Life Questionnaire (AQLQ) Score
Time frame: Baseline, 3, 6, 9 and 12 Months
Structural airway remodeling using CT
Time frame: Baseline and 12 Months
Inflammatory cells and markers in induced sputum
Time frame: Time Frame: Baseline and 12 Months
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