Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).

CompletadoFase 3ClinicalTrials.gov

ID: NCT00242775Tipo: INTERVENTIONALInicio: 1 de may de 2005Fin estimado: 1 de may de 2006

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Diagnosed with asthma since at least 6 months prior to first visit
Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
At least one asthma exacerbation more than one but less than twelve months prior to first visit

Criterios de exclusión

Respiratory infection affecting asthma within 30 days before first visit
Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
Any significant disease or disorder that may jeopardize the safety of the patient

Intervenciones

drug

Budesonide/formoterol Turbuhaler

drug

Salmeterol/fluticasone Diskus

Ubicaciones

Research Site

Mar del Plata, Buenos Aires, Argentina

Research Site

Monte Grande, Buenos Aires, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Santa Fé, Santa Fe Province, Argentina

Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

Research Site

Buenos Aires, Argentina

Research Site

San Miguel de Tucumán, 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.

Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/... | EligiMed