Prediction of Future Risk in Patients With Controlled Asthma

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01565031
• Other study ID #: HULA
• Status: Not yet recruiting
• Phase: N/A
• First received: March 26, 2012
• Last updated: March 27, 2012
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: March 2012
• Source: Hospital Universitario Lucus Augusti
• Contact: Luis Perez de Llano, Md, PhD
• Phone: 34 982296000
• Email: eremos26[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 338
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Spain	Pneumology Service	Lugo

Sponsors (5)

Lead Sponsor	Collaborator
Luis Perez de Llano	Complexo Hospitalario Universitario de A Coruña, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Hospital Galdakao-Usansolo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of asthma control.	Loss of control: Either ACT score = 19 or the development of exacerbation or FEV1 decrease =20%.	12 months	No