None listed
Conditions
Interventions
Once stratified, subjects will be randomized to the treatment phase of the study where they will receive one of the following treatments in a ratio of 1:1:1:
Arm 1 (Experimental): Vilanterol
Vi
Drug: Vilanterol

Drug: Placebo Inhalation Powder DISKUS/ACCUHALER
Arm 2 (Active Comparator): Salmeterol
Placebo inhalation powder via NDPI once daily + Salmeterol 50 mcg inhalation powder twice daily via DISK
Drug: Salmeterol Inhalation Powder

Drug: Placebo Inhalation Powder NDPI
Arm 3 (Placebo Comparator): Placebo
Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via DISKUS/ACCUHALER twice daily for 12 wee
Drug: Placebo Inhalation Powder NDPI

Drug: Placebo Inhalation Powder DISKUS/ACCUHALER
Sponsors
GlaxoSmithKline,
Eligibility
Sex/Gender
All
Age
12 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Contacts
Public ContactSarita Mattos
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed