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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 December 2015 |
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Main ID: |
NCT01974921 |
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Date of registration:
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22/10/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma
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Scientific title:
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Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma |
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Date of first enrolment:
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September 2013 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01974921 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Alfons Torrego, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
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Name:
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Alfons Torrego, M.D. |
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Address:
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Telephone:
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0034 936655972 |
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Email:
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atorrego@santpau.cat |
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Affiliation:
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Key inclusion & exclusion criteria
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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.)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Device: ALAIR Catheter. Radiofrequency system.
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Primary Outcome(s)
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Bronchial smooth muscle.
[Time Frame: Change from baseline in bronchial smooth muscle at 6 months post-treatment..]
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Secondary Outcome(s)
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Radiological findings (thorax HRCT scan)
[Time Frame: Change from baseline in radiological findings at 6 months post-treatment.]
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Number of exacerbations
[Time Frame: Change from baseline in number of exacerbations at 6 months post-treatment.]
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Respiratory function
[Time Frame: Change from baseline in respiratory function at 6 months post-treatment.]
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Questionnaire of asthma control (ACT)
[Time Frame: Change from baseline in ACT at 6 months post-treatment.]
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Number of hospitalizations
[Time Frame: Change from baseline in number of hospitalizations at 6 months post-treatment.]
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Questionnaire of Quality of life (AQLQ)
[Time Frame: Change from baseline in AQLQ at 6 months post-treatment.]
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Inflammatory markers
[Time Frame: Change from baseline in biological inflammatory markers at 6 months post-treatment.]
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Secondary ID(s)
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IIBSP-TER-2013-70
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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