Prediction of Future Risk in Patients With Controlled Asthma

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Procedure: Step-wise down-titration according to international guidelines.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age between 18 and 80. Asthma under control during the last 3 months. Treated with a combination of ICS and long-acting beta-agonist (LABA. Classified as moderate asthma by their attending physician. Exclusion Criteria: Active smoking. Pregnancy. Treatment with oral corticosteroids, omalizumab or immunotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| controlled asthmatics, down-titration<br>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.<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma