Clinical trial NCT01974921: Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma
Official title: Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
Bronchial Thermoplasty
Bronchial smooth muscle
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Bronchial smooth muscle.
timeFrame: Change from baseline in bronchial smooth muscle at 6 months post-treatment..
Secondary outcomes:
measure: Questionnaire of Quality of life (AQLQ)
timeFrame: Change from baseline in AQLQ at 6 months post-treatment.
measure: Questionnaire of asthma control (ACT)
timeFrame: Change from baseline in ACT at 6 months post-treatment.
measure: Number of exacerbations
timeFrame: Change from baseline in number of exacerbations at 6 months post-treatment.
measure: Number of hospitalizations
timeFrame: Change from baseline in number of hospitalizations at 6 months post-treatment.
measure: Respiratory function
timeFrame: Change from baseline in respiratory function at 6 months post-treatment.
measure: Radiological findings (thorax HRCT scan)
timeFrame: Change from baseline in radiological findings at 6 months post-treatment.
measure: Inflammatory markers
timeFrame: Change from baseline in biological inflammatory markers at 6 months post-treatment.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Alfons Torrego, M.D.
role: PRINCIPAL_INVESTIGATOR
References: