A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma

CompletadoFase 3ClinicalTrials.gov

ID: NCT01086384Tipo: INTERVENTIONALInicio: 22 de feb de 2010Fin estimado: 15 de sept de 2011

Traducción no disponible, mostrando original

Resumen

This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

FEV1 of fifty to ninety percent of predicted
Clinical diagnosis of asthma
Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
Currently using inhaled corticosteroid therapy
History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year

Criterios de exclusión

History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
Respiratory infection or oral candidiasis
\- Uncontrolled disease or clinical abnormality
Allergies
Taking another investigational medication or prohibited medication

Intervenciones

drug

Fluticasone Furoate/GW642444

Combination inhaled corticosteroid and long-acting beta2-agonist

drug

Fluticasone furoate

Inhaled corticosteroid

Ubicaciones

GSK Investigational Site

Quilmes, Buenos Aires, Argentina

GSK Investigational Site

Paraná, Entre Ríos Province, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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