Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry.
Condition: Asthma
MeSH terms: Asthma
Intervention: GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate); Placebo
Intervention description: ICS/LABA combination (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI); Placebo administered once daily in the evening via a NDPI
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 311.0
Sex: All
Minimum age: 12 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate
      the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation
      powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult
      subjects of Asian ancestry currently treated with lowe to mid-strength inhaled corticosteroid
      or low-strength combination therapy.
    

Eligibility criteria:

        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 a protocol defined acceptable method of birth control consistently and
             correctly. Female subjects should not be enrolled if they are pregnant, lactating or
             plan to become pregnant during the time of study participation. A serum pregnancy test
             is required for females of childbearing potential at the initial Screening Visit
             (Visit 1) and Visit 5 or Early Withdrawal

          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
             adjustment for Asians [Hankinson, 2010].

          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 nebulised 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, in accordance with the protocol defined
             acceptable dose ranges.

          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 (i.e., lactose or magnesium stearate). •Milk
             Protein Allergy: History of severe milk protein allergy.

          8. Concomitant Medications: Use of the protocol defined prohibited medications prior to
             Screening (Visit 1) or during the study, in accordance with the protocol.

          9. Tobacco Use: Current smoker or subjects with 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 fluticasone furoate/VI combination product study (i.e.,
             HZA113714, HZA106827, HZA106829, HZA106837, HZA106839, HZA106851, HZA113091).

         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.