Prediction of Future Risk in Patients With Controlled Asthma
NCT ID: NCT01565031
Last Updated: 2012-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
338 participants
OBSERVATIONAL
2012-05-31
2015-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy.
* Treatment with oral corticosteroids, omalizumab or immunotherapy.
18 Years
80 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Hospital Clinic of Barcelona
OTHER
Hospital Galdakao-Usansolo
OTHER_GOV
Complexo Hospitalario Universitario de A Coruña
OTHER
Luis Perez de Llano
OTHER
Responsible Party
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Luis Perez de Llano
MD, PhD.
Principal Investigators
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Luis Perez de Llano, Md, PhD
Role: PRINCIPAL_INVESTIGATOR
Servicio Galego de Saude
Locations
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Pneumology Service
Lugo, Lugo, Spain
Countries
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Central Contacts
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Other Identifiers
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HULA
Identifier Type: -
Identifier Source: org_study_id
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