Short summary

The study aims to evaluate changes in inflammatory clinical, physiologic, and microbial parameters and their mutual relationships, induced by bronchial thermoplasty in patients with severe refractory asthma.

Rationale

Bronchial thermoplasty, a novel device-based approach to treat severe persistent asthma, was developed to prevent excessive bronchoconstriction in severe asthma by reducing the amount of smooth muscle mass in the airway wall. A randomized, multicenter sham-controlled trial showed a significant effect on important clinical parameters.

The mechanism whereby thermoplasty leads to a reduction in exacerbations is not clear, and it is as yet unknown whether this procedure might have an effect on airway inflammation. The beneficial effect of thermoplasty on asthma exacerbations might be explained by changes in the airways microbiome and thereby the type of airway inflammation. 

The aims of the study are to investigate the effect of thermoplasty on eosinophil percentages in induced sputum (primary outcome), fraction of exhaled nitric oxide (FeNO), lung function (FEV1/FVC, RV/TLC), asthma control (ACQ) and asthma related quality of life (AQLQ).To relate changes in the above parameters to changes in the airway microbiome.

Description of the cohort

30 patients (Males or females age 18 or greater and less than 65) will fulfil the criteria of severe refractory asthma taking regular maintenance medication (GINA step 4-5)

Data and biological material

Biological material including blood, urine, sputum and broncholaveolar lavage fluid (miniBAL)  will be collected. Lung function measurement and measurement of asthma control and asthma related quality of life will also be performed.

Collaborating researchers and departments

Department of Respiratory Medicine, Copenhagen University Hospital

• Professor and chief physician Vibeke Backer, MD, DMSc

Department of Respiratory Medicine, Hvidovre Hospital

• Professor and chief physician Charlotte Suppli Ulrik, DMSC

Department of Respiratory Medicine, Odense University Hospital

• Chief consultant Hanne Madsen, PhD
• Consultant Niels Bjerring