MedTrace Logo

Prediction of Future Risk in Patients With Controlled Asthma

NCT01565031 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 338

Last updated 2012-03-28

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Hospital Galdakao-Usansolo

    collaborator OTHER_GOV

  • Complexo Hospitalario Universitario de A Coruña

    collaborator OTHER

  • Luis Perez de Llano

    lead OTHER

Principal Investigators

  • Luis Perez de Llano, Md, PhD · Servicio Galego de Saude

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01565031 on ClinicalTrials.gov