Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma

Asthma Clinical Trial

Official title:

Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974921
• Other study ID #: IIBSP-TER-2013-70
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2013
• Last updated: November 19, 2015
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Alfons Torrego, M.D.
• Phone: 0034 936655972
• Email: atorrego[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• ALAIR Catheter. Radiofrequency system.
Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes).

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchial smooth muscle.		Change from baseline in bronchial smooth muscle at 6 months post-treatment..	No
Secondary	Questionnaire of Quality of life (AQLQ)		Change from baseline in AQLQ at 6 months post-treatment.	Yes
Secondary	Questionnaire of asthma control (ACT)		Change from baseline in ACT at 6 months post-treatment.	Yes
Secondary	Number of exacerbations		Change from baseline in number of exacerbations at 6 months post-treatment.	Yes
Secondary	Number of hospitalizations		Change from baseline in number of hospitalizations at 6 months post-treatment.	Yes
Secondary	Respiratory function		Change from baseline in respiratory function at 6 months post-treatment.	Yes
Secondary	Radiological findings (thorax HRCT scan)		Change from baseline in radiological findings at 6 months post-treatment.	No
Secondary	Inflammatory markers	FeNO eNOSE Bronchial biopsies Sputum Serum	Change from baseline in biological inflammatory markers at 6 months post-treatment.	No