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| Name | Class |
|---|---|
| FundaciĂł Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Hospital Galdakao-Usansolo | OTHER_GOV |
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The optimal score to predict unfavourable outcome in well-controlled asthma patients who are undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is warranted to prospectively develop a prognostic system -easy to perform (suitable for use in the clinical rather the research setting)- for asthmatic patients in this clinical setting.
HYPOTHESIS: A simple score system can accurately predict clinical deterioration of asthma in well-controlled patients who are undergoing a step-wise down-titration of their medication according to international guidelines.
METHODS The investigators designed a prospective, multicenter, observational study at five centers in cities across Spain.
The patients group (N = 225) will be evaluated to produce a clinical prediction rule for loss of control. The investigators will consider the following variables in the risk factor analysis: documented history of previous bronchial obstruction (FEV1/FVC < 70%), coefficient of variation (CV) of morning peak expiratory flow (PEF), history of exacerbations, fraction of exhaled nitric oxide (FENO), Asthma control test (ACT), ACT item 3 and adherence.
The score model will be prospectively validated in an independent set of 113 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| controlled asthmatics, down-titration | Adults (age between 18 and 80) with asthma under control (see definitions) during the last 3 months, treated with a combination of ICS and long-acting beta-agonist (LABA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Step-wise down-titration according to international guidelines. | Procedure | The medication will be adjusted according to each patient´s level of control. Depending on the state of control of asthma, the dose will be adjusted up or down (step-up therapy and step-down therapy, respectively) in accordance with GINA. |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of asthma control. | Loss of control: Either ACT score ≤ 19 or the development of exacerbation or FEV1 decrease ≥20%. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Well-controlled asthmatics who are regularly under the care of Allergy or Pneumology specialists.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Perez de Llano, Md, PhD | Contact | 34 982296000 | eremos26@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luis Perez de Llano, Md, PhD | Servicio Galego de Saude | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pneumology Service | Lugo | Lugo | 27004 | Spain |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Complexo Hospitalario Universitario de A Coruña |
| OTHER |
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|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |