A 6-month Randomized, Double-blind, Parallel-group, Multicentre, Placebo-controlled Phase II Study to Compare Anti-asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma

CompletadoFase 2ClinicalTrials.gov

ID: NCT00317044Tipo: INTERVENTIONALInicio: 1 de abr de 2006Fin estimado: 1 de jul de 2008

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Adults with diagnosis of asthma since at least 6 months.
Symptoms of asthma during run-in.
At least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth.

Criterios de exclusión

Patients with clinically relevant abnormalities.
Patients with a smoking history of ≥10 pack-year.
Patients who have had previous surgery on the esophagus or the stomach.

Intervenciones

drug

Esomeprazole

Esomeprazole 40 mg twice daily

drug

Esomeprazole

Esomeprazole 40 mg once daily

drug

Placebo

Placebo twice daily

Ubicaciones

Research Site

Ciudad de Buenos Aires, Argentina, Argentina

Research Site

Monte Grande, Buenos Aires, Argentina

Research Site

Quilmes, Buenos Aires, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Córdoba, Córdoba, Argentina, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

Rosario, Santa Fe, Argentina, Argentina

Research Site

San Miguel de Tucumán, Tucumán, Argentina, Argentina

Research Site

Buenos Aires, Argentina

Patrocinadores

PrincipalAstraZeneca

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