Prediction of Future Risk in Patients With Controlled Asthma
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|ClinicalTrials.gov Identifier: NCT01565031|
Recruitment Status : Unknown
Verified March 2012 by Luis Perez de Llano, Hospital Universitario Lucus Augusti.
Recruitment status was: Not yet recruiting
First Posted : March 28, 2012
Last Update Posted : March 28, 2012
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.
|Condition or disease||Intervention/treatment|
|Asthma||Procedure: Step-wise down-titration according to international guidelines.|
|Study Type :||Observational|
|Estimated Enrollment :||338 participants|
|Official Title:||A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||June 2015|
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).
Procedure: Step-wise down-titration according to international guidelines.
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.
- Loss of asthma control. [ Time Frame: 12 months ]Loss of control: Either ACT score ≤ 19 or the development of exacerbation or FEV1 decrease ≥20%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565031
|Contact: Luis Perez de Llano, Md, PhD||34 email@example.com|
|Lugo, Spain, 27004|
|Principal Investigator:||Luis Perez de Llano, Md, PhD||Servicio Galego de Saude|