Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry
Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry
A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and
 safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once
 daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently
 treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA combination
 therapy
This will be a randomized, double-blind, active-comparator, parallel group, multi-center
 study. At Visit 1 (Screening Visit) subjects who meet all of the inclusion criteria and none
 of the exclusion criteria will enter a two week Run-in period. Subjects will remain on their
 current ICS therapy throughout the Run-in period. At the end of the Run-in period (Visit 2)
 subjects meeting the randomization criteria will enter a 12 week treatment period and receive
 one of the two following treatments: 1) FF (200mcg)/VI (25mcg) administered once daily in the
 evening via a Novel Dry Powder Inhaler (NDPI) 2) Fluticasone propionate 500mcg administered
 twice daily via DISKUS™ Inhaler In addition, all subjects will be supplied with
 albuterol/salbutamol inhalation aerosol to be used as required to treat asthma symptoms.

 Subjects who have not met the randomization criteria at Visit 2 will be withdrawn from the
 study.

 Subjects meeting the randomization criteria will be randomized to one of the two treatment
 groups and will attend the clinic for 3 on-treatment visits at Week 4 (Visit 3), Week 8
 (Visit 4) and Week 12 (Visit 5). Subjects will receive treatment for 12 weeks. A Follow-up
 Visit or Contact (Visit 6) will take place 1 week after completing study medication. All
 clinic visits will take place in the morning. Subjects will participate in the study for a
 maximum of 15 weeks (Screening to Follow-up inclusive). A subject is regarded to have
 completed the study if they complete all phase of the study (Screening, treatment,
 Follow-up).
Inclusion Criteria:

 1. Informed Consent: All subjects must be able and willing to give written informed
 consent to take part in the study

 2. Type of Subject: Outpatients, of Asian ancestry, 12 years of age or older at Visit 1
 (or ≥18 years of age or older if local regulations or the regulatory status of study
 medication permit enrolment of adults only) with a diagnosis of asthma as defined by
 the Global Initiative for Asthma [GINA, 2009] at least 12 weeks prior to Visit 1.

 3. Gender: Male or Eligible Female, defined as non-childbearing potential or childbearing
 potential using an acceptable method of birth control consistently and correctly

 4. Severity of Disease: A best FEV1 of 40%-90% of the predicted normal value at the Visit
 1 Screening visit. Predicted values will be based upon NHANES III using the Asian
 adjustment

 5. Reversibility of Disease: Demonstrated ≥12% and ≥200mL reversibility of FEV1 within
 10-40minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or
 one nebulized treatment with albuterol/salbutamol solution) at the Screening Visit.

 6. Current Anti-Asthma Therapy: All subjects must be using an ICS, with or without LABA,
 for at least 12 weeks prior to Visit 1.

 7. Short-Acting Beta2-Agonists: All subjects must be able to replace their current
 short-acting beta2-agonists with albuterol/salbutamol inhaler at Visit 1 for use as
 needed for the duration of the study. Subjects must be able to withhold
 albuterol/salbutamol for at least 4 hours prior to study visits.

 Exclusion Criteria:

 1. History of Life-threatening asthma: Defined for this protocol as an asthma episode
 that required intubation and/or was associated with hypercapnea, respiratory arrest or
 hypoxic seizures within the last 10 years.

 2. 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 Visit 1 and 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.

 3. Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12
 weeks of Visit 1 or that resulted in overnight hospitalization requiring additional
 treatment for asthma within 6 months prior to Visit 1.

 4. Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia,
 pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia,
 chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other
 respiratory abnormalities other than asthma.

 5. Other Concurrent Diseases/Abnormalities: A subjects must not have any clinically
 significant, uncontrolled condition or disease state that, in the opinion of the
 investigator, would put the safety of the patient at risk through study participation
 or would confound the interpretation of the efficacy results if the condition/disease
 exacerbated during the study.

 6. Oropharyngeal Examination: A subject will not be eligible for the Run-in if he/she has
 clinical visual evidence of candidiasis at Visit 1.

 7. Allergies:

 -  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 new powder inhaler

 -  Milk Protein Allergy: History of severe milk protein allergy.

 8. Concomitant Medications: Use of the protocol defined prohibited medications within the
 prohibited time intervals prior to Screening (Visit 1) or during the study.

 9. Tobacco Use: Current smoker or a smoking history of 10 pack years (e.g., 20
 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products
 within the past 3 months (i.e., cigarettes, cigars, smokeless or pipe tobacco).

 10. Affiliation with Investigator's Site: A subject will not be eligible for this study if
 he/she is an immediate family member of the participating Investigator, sub
 Investigator, study coordinator, or employee of the participating Investigator.

 11. Previous Participation: A subject may not have previously been randomized to treatment
 in another Phase III FF/VI combination product study

 12. Compliance: A subject will not be eligible if he/she or his/her parent or legal
 guardian has any infirmity, disability, disease, or geographical location which seems
 likely (in the opinion of the Investigator ) to impair compliance with any aspect of
 this study protocol, including visit schedule and completion of the daily diaries