Prediction of Future Risk in Patients With Controlled Asthma

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01565031

Enrollment

338

Registered

2012-03-28

Start date

2012-05-31

Completion date

2015-06-30

Last updated

2012-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma

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.

Interventions

PROCEDUREStep-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Spain

Contacts

Primary ContactLuis Perez de Llano, Md, PhD

eremos26@hotmail.com34 982296000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026