Prediction of Future Risk in Patients With Controlled Asthma

• Conditions: Asthma

• Registration Number: NCT01565031
• Lead Sponsor: Luis Perez de Llano

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Last Update Submitted: 2012-03-27
• Study First Posted: 2012-03-28
• Last Update Posted: 2012-03-28
• Study Start: 2012-05
• Primary Completion: 2015-05
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 338

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Loss of asthma control.	12 months	Loss of control: Either ACT score ≤ 19 or the development of exacerbation or FEV1 decrease ≥20%.

Trial Locations

Locations (1)

Pneumology Service; 🇪🇸 Lugo, Spain