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

NCT01498679 | Completed Phase 3 Results

• 1 other identifier: 113719
• Study Type: interventional
• Target: 311
• Locations: 3 countries
• Sites: 28

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period

  Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.

  Baseline and Weeks 1-12 (up to Day 84)

Secondary Outcomes (4)

• Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period

  Baseline and Weeks 1-12 (up to Day 84)

• Mean Change From Baseline in the Percentage of Rescue-free 24- Hour (hr) Periods During the 12-week Treatment Period

  Baseline and Weeks 1-12 (up to Day 84)

• Mean Change From Baseline in the Percentage of Symptom-free 24- Hour (hr) Periods During the 12-week Treatment Period

  Baseline and Weeks 1-12 (up to Day 84)

• Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12

  Baseline and Week 12

Study Arms (2)

fluticasone furoate/vilanterol trifenatate

ACTIVE COMPARATOR

Inhaled corticosteroid (ICS)/Long-acting beta2-agonist (LABA) combination

Drug: GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)

Placebo

PLACEBO COMPARATOR

placebo comparator

Drug: Placebo

Interventions

GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate) DRUG

ICS/LABA combination (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI)

fluticasone furoate/vilanterol trifenatate

Placebo DRUG

Placebo administered once daily in the evening via a NDPI

Placebo

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study.
• 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.
• 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
• 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 \[Hankinson, 2010\].
• 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.
• 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.
• 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

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.
• Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of candidiasis at Visit 1.
• 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.
• Concomitant Medications: Use of the protocol defined prohibited medications prior to Screening (Visit 1) or during the study, in accordance with the protocol.
• 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).
• 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.
• 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).
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (28)

GSK Investigational Site

Shenzhen, Guangdong, 518020, China

Location

GSK Investigational Site

Zhanjiang, Guangdong, 524001, China

Location

GSK Investigational Site

Nanning, Guangxi, 530021, China

Location

GSK Investigational Site

Haikou, Hainan, 570311, China

Location

GSK Investigational Site

Shenyang, Liaoning, 110015, China

Location

GSK Investigational Site

Yinchuan, Ningxia, 750004, China

Location

GSK Investigational Site

Xi'an, Shaanxi, 710032, China

Location

GSK Investigational Site

Qingdao, Shandong, 266071, China

Location

GSK Investigational Site

Hangzhou, Zhejiang, 310003, China

Location

GSK Investigational Site

Beijing, 100029, China

Location

GSK Investigational Site

Beijing, 100034, China

Location

GSK Investigational Site

Beijing, 100050, China

Location

GSK Investigational Site

Chongqing, 400037, China

Location

GSK Investigational Site

Chongqing, China

Location

GSK Investigational Site

Hangzhou, 310016, China

Location

GSK Investigational Site

Shanghai, 200433, China

Location

GSK Investigational Site

Marilao, Bulacan, 3019, Philippines

Location

GSK Investigational Site

Quezon City, 1101, Philippines

Location

GSK Investigational Site

Bucheon-si, Gyeonggi-Do, 420-767, South Korea

Location

GSK Investigational Site

Cheongju, Chungcheongbuk-do, 361-711, South Korea

Location

GSK Investigational Site

Ilsanseo-gu, Goyang-si, Gyeonggi-do, 411706, South Korea

Location

GSK Investigational Site

Pusan, 602-739, South Korea

Location

GSK Investigational Site

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 130-709, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

Location

GSK Investigational Site

Seoul, 152-703, South Korea

Location

Related Publications (1)

• Lin J, Tang H, Chen P, Wang H, Kim MK, Crawford J, Jacques L, Stone S. Efficacy and safety evaluation of once-daily fluticasone furoate/vilanterol in Asian patients with asthma uncontrolled on a low- to mid-strength inhaled corticosteroid or low-dose inhaled corticosteroid/long-acting beta2-agonist. Allergy Asthma Proc. 2016 Jul;37(4):302-10. doi: 10.2500/aap.2016.37.3968.

  PMID: 27401316 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate-vilanterol trifenatate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 8, 2017
• Results First Posted: April 1, 2014

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (16); KR (10); PH (2)