A Study to Assess the Bronchodilator Effect of a Single Dose of Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 Micrograms (mcg) Combination When Administered in Adult Patients With Asthma
A Study to Assess the Bronchodilator Effect of a Single Dose of Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 Micrograms (mcg) Combination When Administered in Adult Patients With Asthma
The study will be a randomized, double-blind, placebo controlled cross-over study in 32 adult
 subjects with moderately severe asthma. In this study the bronchodilator effect of a single
 morning dosing of FF/VI combination 100/25 mcg will be determined by spirometry. After the
 screening the subject will be randomized and will be assigned to one of two treatment
 sequences (AB or BA, where A is placebo and B is FF/VI 100/25 mcg). Between the two treatment
 periods there will be a washout period of 7-14 days. A serial forced expiratory volume in one
 second (FEV1) measurements will be taken at 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and
 72 hours post dose. Safety assessments will include vital signs, electrocardiograms (ECGs),
 adverse event (AE) monitoring and laboratory safety tests however, these will not constitute
 study endpoints. The results of the study will provide supporting information to prescribers
 on the bronchodilator effect of FF/VI over 72 hours.
Inclusion Criteria:

 -  Asthma: A doctor diagnosis of asthma.

 -  Age of subject: 18 to 65 years of age inclusive, at the time of signing the informed
 consent.

 -  Severity of Disease: A screening pre-bronchodilator FEV1 >=60% of predicted.

 -  Reversibility of Disease: Demonstrated presence of reversible airway disease at
 screening.

 -  Current Therapy: On inhaled corticosteroid (ICS) with or without a SABA for at least
 12 weeks prior to screening. Able to stop current Short-Acting Beta2-Agonists (SABA)
 and replace with albuterol/salbutamol inhaler

 -  Body weight and BMI: Body weight >=50 kilogram (kg) and Body Mass Index (BMI) within
 the range 19.0 to 29.9 kilogram per square meter (kg/m^2) (inclusive).

 -  Gender: Male or female. A female subject is eligible to participate if she is of:

 Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose
 menopausal status is in doubt will be required to use one of the contraception methods if
 they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to
 allow confirmation of post-menopausal status prior to study enrollment.

 Child-bearing potential and agrees to use one of the contraception methods for an
 appropriate period of time (as determined by the product label or investigator) prior to
 the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female
 subjects must agree to use contraception until completion of the follow-up visit.

 -  Liver criteria: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)
 <2x Upper limit of normal (ULN); alkaline phosphatase and bilirubin <=1.5xULN
 (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct
 bilirubin <35%).

 -  Consent: Capable of giving written informed consent, which includes compliance with
 the requirements and restrictions listed in the consent form.

 Exclusion Criteria:

 -  A history of life-threatening asthma.

 -  Other significant pulmonary diseases: pneumonia, pneumothorax, atelectasis, pulmonary
 fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic
 obstructive pulmonary disease, or other respiratory abnormalities other than asthma.

 -  Respiratory Infection: Culture-documented or suspected bacterial or viral infection of
 the upper or lower respiratory tract, sinus or middle ear that is not resolved within
 4 weeks of screening that; led to a change in asthma management OR in the opinion of
 the Investigator, is expected to affect the subject's asthma status OR the subject's
 ability to participate in the study.

 -  Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12
 weeks of screening or that resulted in overnight hospitalization requiring additional
 treatment for asthma within 6 months prior to screening.

 -  Concomitant Medications: Use of the medications, ICS were prohibited for each study
 period from 24 hours prior to dosing to 72 hours after dosing; Long acting beta
 agonist (LABA), leukotriene receptor antagonist (LTRA) or long acting muscarinic
 anatagonist (LAMA) were prohibited for 12 weeks prior to screening; High doses of an
 ICS were prohibited for 8 weeks prior to screening; Oral steroids were prohibited for
 12 weeks prior to screening; Potent CYPP3A4 inhibitors were prohibited within 4 weeks
 prior to dosing. The following medications may not be used during the study from first
 dosing to the end of period 2 inclusive: Anticonvulsants, Polycyclic antidepressants,
 β-adrenergic blocking agents, Phenothiazines and Monoamine oxidase (MAO) inhibitors.

 -  Other concurrent Diseases/Abnormalities: A subject has any clinically significant,
 uncontrolled condition or disease state that, in the opinion of the investigator,
 would put the safety of the subject at risk through study participation or would
 confound the interpretation of the study results if the condition/disease exacerbated
 during the study.

 -  Oropharyngeal examination: A subject will not be eligible if he/she has clinical
 visual evidence of oral candidiasis at screening.

 -  Pregnancy and Lactating Females:Pregnant females as determined by positive serum human
 chorionic gonadotropin (hCG) test at screening or by positive urine hCG test prior to
 dosing. Lactating females.

 -  Allergies: Milk Protein Allergy: History of severe milk protein allergy. Drug Allergy:
 Any adverse reaction including immediate or delayed hypersensitivity to any
 beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic
 corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry
 powder inhaler (DPI) (i.e., lactose or magnesium stearate). Historical Allergy:
 History of drug or other allergy that, in the opinion of the investigator or GSK
 Medical Monitor, contraindicates their participation.

 -  12-Lead ECG abnormality: Significant abnormality in the 12-lead electrocardiogram
 (ECG) performed at screening.

 -  Tobacco Use: Current smokers or a smoking history of >=10 pack years. A subject may
 not have used any inhaled tobacco products in the 12 month period preceding the
 screening visit.

 -  Previous Participation: Exposure to more than four new chemical entities within 12
 months prior to the first dosing day.