Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
HZA106827: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Parallel Group Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder Alone in the Treatment of Persistent Asthma in Adults and Adolescents
1 other identifier
interventional
612
6 countries
70
Brief Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Aug 2010
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2010
CompletedFirst Posted
Study publicly available on registry
July 19, 2010
CompletedStudy Start
First participant enrolled
August 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2011
CompletedResults Posted
Study results publicly available
July 30, 2013
CompletedFebruary 14, 2018
January 1, 2018
1.1 years
July 15, 2010
May 30, 2013
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1measurement taken at the clinic visit while still on-treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the Week 12 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, region, sex, age, and treatment group. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing m
Baseline and Week 12
Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 12 FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.
Baseline and Week 12
Secondary Outcomes (5)
Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
Baseline and Week 12
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
Baseline and Week 12
Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12/Early Withdrawal
Baseline and Week 12/Early Withdrawal
Number of Participants Who Withdrew Due to Lack of Efficacy During the 12-week Treatment Period
From the first dose of the study medication up to Week 12/Early Withdrawal
Serial FEV1 Over 0-1 Hour Post-dose at Randomization
Randomization
Other Outcomes (11)
Clinic Visit 12-hour Post-dose FEV1 at Week 12
Week 12
Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Baseline
Baseline
Weighted Mean Serial FEV1 Over 0-4 Hours Post-dose at Baseline and Week 12
Baseline and Week 12
- +8 more other outcomes
Study Arms (3)
Fluticasone furoate/Vilanterol (GW642444)
EXPERIMENTALFluticasone furoate/Vilanterol inhalation powder once daily for 12 weeks
Fluticasone Furoate
EXPERIMENTALFluticasone furoate inhalation powder once daily for 12 weeks
Placebo
PLACEBO COMPARATORPlacebo inhalation powder once daily for 12 weeks
Interventions
Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 12 weeks
Fluticasone Furoate Inhalation Powder inhaled orally once daily for 12 weeks
Eligibility Criteria
You may qualify if:
- Outpatients at least 12 years of age
- Male and female; female subjects of childbearing potential must be willing to use birth control
- Pre-bronchodilator FEV1 of 40-90% predicted normal
- Reversibility FEV1 of at least 12% and 200mL
- Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit
You may not qualify if:
- History of life-threatening asthma during last 10 years
- Respiratory infection or oral candidiasis
- Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment
- Uncontrolled disease or clinical abnormality
- Allergies to study drugs or the excipients
- Taking another investigational medication or prohibited medication
- Night shift workers
- Current smokers or subjects with a smoking history of at least 10 pack years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (70)
GSK Investigational Site
Bell Gardens, California, 90201, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Roseville, California, 95661, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
GSK Investigational Site
River Forest, Illinois, 60305, United States
GSK Investigational Site
Columbia, Maryland, 21044, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Lake Oswego, Oregon, 97035, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Sugar Land, Texas, 77479, United States
GSK Investigational Site
Murray, Utah, 84107, United States
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Oranienburg, Brandenburg, 16515, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Gelnhausen, Hesse, 63571, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 10789, Germany
GSK Investigational Site
Berlin, 12165, Germany
GSK Investigational Site
Berlin, 14057, Germany
GSK Investigational Site
Hamburg, 20354, Germany
GSK Investigational Site
Fukuoka, 811-1394, Japan
GSK Investigational Site
Hiroshima, 732-0052, Japan
GSK Investigational Site
Hokkaido, 064-0801, Japan
GSK Investigational Site
Hyōgo, 672-8048, Japan
GSK Investigational Site
Ishikawa, 920-8530, Japan
GSK Investigational Site
Kagawa, 762-0031, Japan
GSK Investigational Site
Kanagawa, 252-0143, Japan
GSK Investigational Site
Kyoto, 603-8161, Japan
GSK Investigational Site
Okinawa, 901-2132, Japan
GSK Investigational Site
Tokyo, 158-0083, Japan
GSK Investigational Site
Tokyo, 171-0014, Japan
GSK Investigational Site
Tokyo, 194-0023, Japan
GSK Investigational Site
Tarnów, 33-100, Poland
GSK Investigational Site
Tczew, 83-110, Poland
GSK Investigational Site
Wroclaw, 53-301, Poland
GSK Investigational Site
Zawadzkie, 47-120, Poland
GSK Investigational Site
Bucharest, 020674, Romania
GSK Investigational Site
Cluj-Napoca, 400371, Romania
GSK Investigational Site
Craiova, 200642, Romania
GSK Investigational Site
Deva, 330084, Romania
GSK Investigational Site
Piteşti, 110084, Romania
GSK Investigational Site
Ploieşti, 100550, Romania
GSK Investigational Site
Suceava, 720284, Romania
GSK Investigational Site
Timișoara, 300310, Romania
GSK Investigational Site
Dnipropetrovsk, 49006, Ukraine
GSK Investigational Site
Dnipropetrovsk, 49051, Ukraine
GSK Investigational Site
Ivano-Frankivsk, 76018, Ukraine
GSK Investigational Site
Kharkiv, 61035, Ukraine
GSK Investigational Site
Kiev, 03680, Ukraine
GSK Investigational Site
Kyiv, 02091, Ukraine
GSK Investigational Site
Kyiv, 02660, Ukraine
GSK Investigational Site
Kyiv, 03038, Ukraine
GSK Investigational Site
Kyiv, 03115, Ukraine
GSK Investigational Site
Kyiv, 04201, Ukraine
GSK Investigational Site
Simferopol, 95043, Ukraine
GSK Investigational Site
Zaporizhia, 69076, Ukraine
Related Publications (5)
O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
PMID: 27881132DERIVEDGross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.
PMID: 26704701DERIVEDBleecker ER, Lotvall J, O'Byrne PM, Woodcock A, Busse WW, Kerwin EM, Forth R, Medley HV, Nunn C, Jacques L, Bateman ED. Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):553-61. doi: 10.1016/j.jaip.2014.02.010. Epub 2014 Apr 24.
PMID: 25213048DERIVEDSvedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19. No abstract available.
PMID: 24966061DERIVEDSvedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.
PMID: 24314123DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
July 15, 2010
First Posted
July 19, 2010
Study Start
August 20, 2010
Primary Completion
October 1, 2011
Study Completion
October 19, 2011
Last Updated
February 14, 2018
Results First Posted
July 30, 2013
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.