A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years

CompletadoFase 3ClinicalTrials.gov

ID: NCT00839800Tipo: INTERVENTIONALInicio: 1 de feb de 2009Fin estimado: 1 de feb de 2011

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.

Criterios de exclusión

Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.
Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.

Intervenciones

drug

Symbicort Turbuhaler

160/4.5 µg

drug

Terbutaline Turbuhaler

0.4 mg

Ubicaciones

Research Site

Buenos Aires, Argentina, Argentina

Research Site

Capital Federal, Buenos Aires, Argentina

Research Site

Mar del Plata, Buenos Aires, Argentina

Research Site

Monte Grande, Buenos Aires, Argentina

Research Site

Quilmes, Buenos Aires, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

Santa Fe, Santa Fe Province, Argentina

Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

Research Site

Ciudad de Buenos Aires, 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.

A Comparison of Symbicort® SMART (160/4.5μg) and Symbicor... | EligiMed