A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP, PLACEBO CONTROLLED (ON INHALED CORTICOSTEROID MEDICATION), MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VILANTEROL INHALATION POWDER (GW642444) AND SALMETEROL, COMPARED WITH PLACEBO IN THE TREATMENT OF PERSISTENT ASTHMA EN ADULTOS Y ADOLESCENTES NO CONTROLADOS CON CORTICOSTEROIDES INHALADOS.

GlaxoSmithKline,0 sites0 target enrollmentSeptember 29, 2010

Overview

No summary available.

Registry

who.int

Start Date

September 29, 2010

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

GlaxoSmithKline,

•1\.Outpatient at least 12 years of age
•2\.Both genders; females of childbearing potential must be willing to use birth control method
•3\.Clinical diagnosis of asthma for ≥12 weeks
•4\.Best pre\-bronchodilator FEV1 of 40%\-90% predicted
•5\.Reversibility of FEV1 of at least 12% and 200ml
•6\.Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
•7\.Ability to use replace current short\-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits.
•Other protocol\-defined randomization to treatment inclusion criteria apply.

•1\.History of life\-threatening asthma
•2\.Respiratory infection within last 4 weeks leading to change in asthma management
•3\.Asthma exacerbation within last 3 months or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1\.
•4\.Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
•5\.Subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half\-lives (t 1/2\) of the prior investigational study, whichever is the longer of the two.
•6\.Allergies to study drugs, study drugs´ excipients, or medications related to study drugs
•7\.Previous participation in a vilanterol (GW642444\) study
•Other protocol\-defined randomization to treatment exclusion criteria apply.