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The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.
Bronchial thermoplasty is a new therapeutic tool for severe and uncontrolled asthma patients. Clinical trials have demonstrated clinical benefits regarding quality of life and exacerbations. Animal models suggested the reduction of bronchial smooth muscle as the principal responsible for the clinical benefits observed in asthma patients treated in the clinical trials, although there is little information about its mechanism of action, and limited to a very small number of case reports. Given that the mechanism of action of bronchial thermoplasty is still not well understood, we proposed a biological study in asthma patients treated with bronchial thermoplasty with the purpose to analyze changes in inflammatory markers and histological samples, as well as its correlation with clinical outcomes in real practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchial thermoplasty | Experimental | ALAIR Catheter. Radiofrequency system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALAIR Catheter. Radiofrequency system. | Device | Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes). |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchial smooth muscle. | Change from baseline in bronchial smooth muscle at 6 months post-treatment.. |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire of Quality of life (AQLQ) | Change from baseline in AQLQ at 6 months post-treatment. | |
| Questionnaire of asthma control (ACT) | Change from baseline in ACT at 6 months post-treatment. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alfons Torrego, M.D. | Contact | 0034 936655972 | 5967 | atorrego@santpau.cat |
| Name | Affiliation | Role |
|---|---|---|
| Alfons Torrego, M.D. | FundaciĂł Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08025 | Spain |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Number of exacerbations |
| Change from baseline in number of exacerbations at 6 months post-treatment. |
| Number of hospitalizations | Change from baseline in number of hospitalizations at 6 months post-treatment. |
| Respiratory function | Change from baseline in respiratory function at 6 months post-treatment. |
| Radiological findings (thorax HRCT scan) | Change from baseline in radiological findings at 6 months post-treatment. |
| Inflammatory markers | FeNO eNOSE Bronchial biopsies Sputum Serum | Change from baseline in biological inflammatory markers at 6 months post-treatment. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |