Asthma Clinical Trial
Official title:
Efficacy of the Combination of General Relaxation (Mindfulness) and Respiratory (Buteyko) Techniques for the Improvement of Poorly Controlled Asthma. The MBA Study
Administration of a combined program for general (Mindfulness) and respiratory (Buteyko technique) relationship in patients with poorly controlled asthma and anxiety/stress to determine if it provides an improvement in current control and future risk of asthma.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Diagnosis of poorly controlled asthma - In treatment with a combination of ICS/LABA at medium doses - Anxiety and/or functional dyspnea - Attended in the outpatient consultations of the Asthma Unit of the Pneumology and Allergy Service of the Hospital de la Santa Creu i Sant Pau in Barcelona Exclusion Criteria: - Severe asthma exacerbation in the last 30 days - Severe disabling comorbidity - Severe psychiatric illness - Inability to complete questionnaires. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90. | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Spain,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | % patients with changed asthma control | Changes in asthma symptoms measured with the asthma control test (minimum 5 as worse value; maximum 25, as the best value) | 1 year | |
Primary | Changes in asthma exacerbation | Changes in asthma exacerbation measured by number of hospital admissions and medical treatments received | 1 year | |
Secondary | Anxiety | Improvement of the anxiety level measured with the test hospital anxiety and depression scale (minimum 0 as the best value, maximum 42 as the worst value) | 1 year | |
Secondary | Functional dyspnea | Changes in functional dyspnea measured with the test Nijmegen (minimum 0 as the worst value, maximum 64 as the worst value) | 1 year | |
Secondary | Pulmonary function | Changes in pulmonary function with spirometry (Forced Expiratory Volume in 1 Second and forced vital capacity) | 1 year | |
Secondary | Bronchial inflammation | Changes in bronchial inflammation with FENO | 1 year | |
Secondary | Therapeutic adherence of patients to inhalers | Changes in therapeutic adherence of patients to inhalers with the "Inhaler Adhesion Test" | 1 year |
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