A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects

CompletadoFase 3ClinicalTrials.gov

ID: NCT00419744Tipo: INTERVENTIONALInicio: 1 de ene de 2007Fin estimado: 1 de ago de 2009

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

A current clinical diagnosis of COPD with COPD symptoms for more than 2 years
Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit

Criterios de exclusión

A history of asthma at or after 18 years of age
A history of allergic rhinitis at or after 18 years of age
Subjects taking oral steroids
Any significant disease or disorder that may jeopardize a subject's safety

Intervenciones

drug

Budesonide/formoterol (SYMBICORT) pMDI

drug

Formoterol Turbuhaler

Ubicaciones

Research Site

Capital Federal, Buenos Aires, Argentina

Research Site

Mar del Plata, Buenos Aires, Argentina

Research Site

Nueve de Julio, Buenos Aires, Argentina

Research Site

Ramos Mejía, Buenos Aires, Argentina

Research Site

Vicente López, Buenos Aires, Argentina

Research Site

Corrientes, Corrientes Province, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Mendoza, Mendoza Province, Argentina

Research Site

San Juan, San Juan Province, Argentina

Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalAstraZeneca

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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