Asthma
Conditions
Keywords
Asthma, Bronchial Thermoplasty, Bronchial smooth muscle
Brief summary
The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.
Detailed description
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.
Interventions
DEVICEALAIR Catheter. Radiofrequency system.
Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes).
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients under 18 years old. * Severe persistent asthma according to GINA. * Inhaled corticosteroids and long-acting ß2 agonist (LABA). * Other medications for asthma, as oral corticosteroids, anti-IgE, theofiline, etc. are also acceptable. * Asthma Quality of Life Questionnaire (AQLQ) \< 7 * Asthma Control Test (ACT) \< 19 * ≥ 2 exacerbations in last year
Exclusion criteria
* History of cigarette smoking with \> 15 pack/years. * Other respiratory diseases. * Comorbidity that can justify the symptoms of the patients. * Life-threating unstable asthma. * Any contraindication to perform a bronchoscopy (respiratory insufficiency, coagulation abnormalities, allergy to sedative drugs, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bronchial smooth muscle. | Change from baseline in bronchial smooth muscle at 6 months post-treatment.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire of asthma control (ACT) | Change from baseline in ACT at 6 months post-treatment. | — |
| 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. | — |
| Questionnaire of Quality of life (AQLQ) | Change from baseline in AQLQ at 6 months post-treatment. | — |
| Radiological findings (thorax HRCT scan) | Change from baseline in radiological findings at 6 months post-treatment. | — |
| Inflammatory markers | Change from baseline in biological inflammatory markers at 6 months post-treatment. | FeNO eNOSE Bronchial biopsies Sputum Serum |
| Respiratory function | Change from baseline in respiratory function at 6 months post-treatment. | — |
Countries
Spain
Contacts
Primary ContactAlfons Torrego, M.D.
Outcome results
None listed