Overview

Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry.

Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluticasone
Xhance
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.