Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents

A Randomised, Double-blind, Double-dummy, Placebo Controlled (With Rescue Medication), Multicenter Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.

A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Fluticasone furoate; Drug: Placebo; Drug: Fluticasone propionate

Detailed Description

This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). The primary endpoint consists of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The nominated powered secondary endpoint is the change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Gozée, Belgium, 6534
    • GSK Investigational Site
  • Halen, Belgium, 3544
    • GSK Investigational Site
  • Hamois (Natoye), Belgium, 5360
    • GSK Investigational Site
  • Tremelo, Belgium, 3120
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10367
    • GSK Investigational Site
  • Berlin, Germany, 12157
    • GSK Investigational Site
  • Berlin, Germany, 12043
    • GSK Investigational Site
  • Brandenburg
    • Ruedersdorf, Brandenburg, Germany, 15562
      • GSK Investigational Site
    • Schwedt, Brandenburg, Germany, 16303
      • GSK Investigational Site
  • Hessen
    • Eschwege, Hessen, Germany, 37269
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30173
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45359
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39112
      • GSK Investigational Site
  • Thueringen
    • Erfurt, Thueringen, Germany, 99084
      • GSK Investigational Site
    • Schmoelln, Thueringen, Germany, 04626
      • GSK Investigational Site
• Poland
  • Debica, Poland, 39-200
    • GSK Investigational Site
  • Kielce, Poland, 25-751
    • GSK Investigational Site
  • Lodz, Poland, 93-513
    • GSK Investigational Site
  • Lomza, Poland, 18-400
    • GSK Investigational Site
  • Sopot, Poland, 81-741
    • GSK Investigational Site
  • Szczecin, Poland, 71-124
    • GSK Investigational Site
• Romania
  • Bucharest, Romania, 020125
    • GSK Investigational Site
  • Bucharest, Romania, 022102
    • GSK Investigational Site
  • Bucharest, Romania, 050042
    • GSK Investigational Site
  • Bucharest, Romania, 050526
    • GSK Investigational Site
  • Bucuresti, Romania, 041914
    • GSK Investigational Site
  • Iasi, Romania, 700115
    • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • GSK Investigational Site
    • Montgomery, Alabama, United States, 36106
      • GSK Investigational Site
  • Arizona
    • Green Valley, Arizona, United States, 85614
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • Bakersfield, California, United States, 93301
      • GSK Investigational Site
    • Encinitas, California, United States, 92024
      • GSK Investigational Site
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Huntington Beach, California, United States, 92647
      • GSK Investigational Site
    • Long Beach, California, United States, 90808
      • GSK Investigational Site
    • Long Beach, California, United States, 90813
      • GSK Investigational Site
    • Newport Beach, California, United States, 92663
      • GSK Investigational Site
    • Orange, California, United States, 92868
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • Rolling Hills Estates, California, United States, 90274
      • GSK Investigational Site
    • San Diego, California, United States, 92123
      • GSK Investigational Site
    • San Diego, California, United States, 92120
      • GSK Investigational Site
    • San Diego, California, United States, 92128
      • GSK Investigational Site
    • San Diego, California, United States, 92103-8415
      • GSK Investigational Site
    • San Jose, California, United States, 95117
      • GSK Investigational Site
  • Florida
    • Cutler Bay, Florida, United States, 33189
      • GSK Investigational Site
    • Edgewater, Florida, United States, 32132
      • GSK Investigational Site
    • Miami, Florida, United States, 33155
      • GSK Investigational Site
    • Miami, Florida, United States, 33185
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
  • Georgia
    • Albany, Georgia, United States, 31707
      • GSK Investigational Site
    • Columbus, Georgia, United States, 31904
      • GSK Investigational Site
  • Illinois
    • Shiloh, Illinois, United States, 62269
      • GSK Investigational Site
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • GSK Investigational Site
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • GSK Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • GSK Investigational Site
    • Sunset, Louisiana, United States, 70584
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • GSK Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63141
      • GSK Investigational Site
  • Nebraska
    • Bellevue, Nebraska, United States, 68123-4303
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • GSK Investigational Site
  • North Carolina
    • Shelby, North Carolina, United States, 28152
      • GSK Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45459
      • GSK Investigational Site
    • Franklin, Ohio, United States, 45005
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • GSK Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • GSK Investigational Site
  • Pennsylvania
    • Collegeville, Pennsylvania, United States, 19426
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15241
      • GSK Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • GSK Investigational Site
    • Orangeburg, South Carolina, United States, 29118
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78750
      • GSK Investigational Site
    • Dallas, Texas, United States, 75225
      • GSK Investigational Site
    • Houston, Texas, United States, 77054
      • GSK Investigational Site
    • Kerrville, Texas, United States, 78028
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78224
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78251
      • GSK Investigational Site
    • Waco, Texas, United States, 76712
      • GSK Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23225
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent
• Outpatient at least 12 years of age
• Both genders; females of child bearing potential must be willing to use approved birth control method
• Pre-bronchodilator FEV1 of 40-90% predicted
• Reversibility FEV1 of at least 12% and 200mLs
• Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks prior to first visit

Exclusion Criteria:

• History of life threatening asthma
• Respiratory infection or candidiasis
• Asthma exacerbation within 6 months prior to first visit
• Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
• Allergies to study drugs, study drug excipients, medications related to study drugs
• Taking another investigational medication or medication prohibited for use during this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fluticasone Furoate OD and Placebo BID; Fluticasone furoate inhalation powder once daily and placebo inhalation powder twice daily for 24 weeks	Drug: Fluticasone furoate; Fluticasone furoate inhalation powder, 100 µg; Drug: Placebo; Placebo inhalation powder
ACTIVE_COMPARATOR: Fluticasone Propionate BID and Placebo OD; Fluticasone propionate inhalation powder twice daily and placebo inhalation powder once daily for 24 weeks	Drug: Placebo; Placebo inhalation powder; Drug: Fluticasone propionate; Fluticasone propionate inhalation powder, 250 µg
PLACEBO_COMPARATOR: Placebo only BID; Placebo inhalation powder twice daily for 24 weeks	Drug: Placebo; Placebo inhalation powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period	FEV1 is a measure of lung function and is 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) FEV1 measurement taken at the clinic visit at the end of the dosing interval. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. 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 measurements.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period	The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.	Baseline and Week 24
Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period	PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Trough evening PEF is the PM PEF measured approximately 24 hours after the last evening administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.	From Baseline up to Week 12 and Week 24
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period	PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.	From Baseline up to Week 12 and Week 24
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period	The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.	Baseline and Week 24
Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24	The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the ages of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment." The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment"). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline.	Baseline, Week 12, and Week 24

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: June 30, 2010
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 16, 2012

Study Registration Dates

• First Submitted: July 8, 2010
• First Submitted That Met QC Criteria: July 8, 2010
• First Posted (ESTIMATE): July 12, 2010

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: fluticasone propionate; Fluticasone furoate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: 112059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Dataset Specification
   Information identifier: 112059
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 112059
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 112059
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Annotated Case Report Form
   Information identifier: 112059
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 112059
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: 112059
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Informed Consent Form
   Information identifier: 112059
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register