A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma

CompletadoFase 3ClinicalTrials.gov

ID: NCT01444430Tipo: INTERVENTIONALInicio: 1 de dic de 2011Fin estimado: 1 de oct de 2015

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

Descripción detallada

A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
Male or Female, ≥12 years of age
Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
Patient must have history of at least 1 asthma exacerbation including one of the following:
requiring treatment with systemic corticosteroids
an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire

Criterios de exclusión

Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
Patient must not meet unstable asthma severity criteria as listed in the protocol
Peak expiratory flow must not be below 50% o predicted normal
Pregnancy, breast-feeding or planned pregnancy during the study

Intervenciones

drug

Symbicort pMDI

Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation.

drug

budesonide pMDI

Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Monte Grande, Argentina

Research Site

Quilmes, Argentina

Research Site

Ranelagh, Argentina

Research Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalAstraZeneca

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