Asthma Clinical Trial
Official title:
A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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