Prediction of Future Risk in Patients With Controlled Asthma

NCT01565031 | Unknown

• 1 other identifier: HULA
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Loss of asthma control.

  Loss of control: Either ACT score ≤ 19 or the development of exacerbation or FEV1 decrease ≥20%.

  12 months

Study Arms (1)

controlled asthmatics, down-titration

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.

Interventions

Step-wise down-titration according to international guidelines. PROCEDURE

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.

controlled asthmatics, down-titration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Well-controlled asthmatics who are regularly under the care of Allergy or Pneumology specialists.

You may qualify if:

• 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.

You may not qualify if:

• Active smoking.
• Pregnancy.
• Treatment with oral corticosteroids, omalizumab or immunotherapy.

Sponsors & Collaborators

• Luis Perez de Llano: lead
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Galdakao-Usansolo: collaborator
• Complexo Hospitalario Universitario de A Coruña: collaborator

Study Sites (1)

Pneumology Service

Lugo, Lugo, 27004, Spain

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Luis Perez de Llano, Md, PhD

  Servicio Galego de Saude

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Perez de Llano, Md, PhD

CONTACT

34 982296000; eremos26@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD.

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 28, 2012

Record last verified: 2012-03

Locations

ES (1)