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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159912
First Posted: July 12, 2010
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Asthma Drug: Fluticasone propionate Drug: Fluticasone furoate Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline and Week 24 ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period [ Time Frame: Baseline and Week 24 ]
    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.

  • 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 [ Time Frame: From Baseline up to Week 12 and Week 24 ]
    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.

  • Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period [ Time Frame: From Baseline up to Week 12 and Week 24 ]
    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.

  • Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period [ Time Frame: Baseline and Week 24 ]
    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.

  • Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24 [ Time Frame: Baseline, 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.


Enrollment: 350
Study Start Date: June 30, 2010
Study Completion Date: January 16, 2012
Primary Completion Date: January 1, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Fluticasone propionate
Fluticasone propionate inhalation powder, 250 µg
Drug: Placebo
Placebo inhalation powder
Placebo Comparator: Placebo only BID
Placebo inhalation powder twice daily for 24 weeks
Drug: Placebo
Placebo inhalation powder

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159912


  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35209
GSK Investigational Site
Montgomery, Alabama, United States, 36106
United States, Arizona
GSK Investigational Site
Green Valley, Arizona, United States, 85614
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
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, 92103-8415
GSK Investigational Site
San Diego, California, United States, 92120
GSK Investigational Site
San Diego, California, United States, 92123
GSK Investigational Site
San Diego, California, United States, 92128
GSK Investigational Site
San Jose, California, United States, 95117
United States, Florida
GSK Investigational Site
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
United States, Georgia
GSK Investigational Site
Albany, Georgia, United States, 31707
GSK Investigational Site
Columbus, Georgia, United States, 31904
United States, Illinois
GSK Investigational Site
Shiloh, Illinois, United States, 62269
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66215
United States, Kentucky
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
GSK Investigational Site
Sunset, Louisiana, United States, 70584
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21236
United States, Missouri
GSK Investigational Site
Columbia, Missouri, United States, 65203
GSK Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Nebraska
GSK Investigational Site
Bellevue, Nebraska, United States, 68123-4303
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
United States, North Carolina
GSK Investigational Site
Shelby, North Carolina, United States, 28152
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Dayton, Ohio, United States, 45459
GSK Investigational Site
Franklin, Ohio, United States, 45005
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Investigational Site
Collegeville, Pennsylvania, United States, 19426
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
GSK Investigational Site
Greenville, South Carolina, United States, 29607
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Texas
GSK Investigational Site
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, 78224
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78251
GSK Investigational Site
Waco, Texas, United States, 76712
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23225
Belgium
GSK Investigational Site
Gozée, Belgium, 6534
GSK Investigational Site
Halen, Belgium, 3544
GSK Investigational Site
Hamois (Natoye), Belgium, 5360
GSK Investigational Site
Tremelo, Belgium, 3120
Germany
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
GSK Investigational Site
Schwedt, Brandenburg, Germany, 16303
GSK Investigational Site
Eschwege, Hessen, Germany, 37269
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
GSK Investigational Site
Erfurt, Thueringen, Germany, 99084
GSK Investigational Site
Schmoelln, Thueringen, Germany, 04626
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 12043
GSK Investigational Site
Berlin, Germany, 12157
Poland
GSK Investigational Site
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
Romania
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112059
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112059
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112059
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 112059
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112059
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112059
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112059
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01159912     History of Changes
Other Study ID Numbers: 112059
First Submitted: July 8, 2010
First Posted: July 12, 2010
Results First Submitted: June 6, 2013
Results First Posted: August 8, 2013
Last Update Posted: November 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://

Keywords provided by GlaxoSmithKline:
fluticasone propionate
Fluticasone furoate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents