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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fluticasone propionate
Fluticasone furoate
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring fluticasone propionate, Fluticasone furoate

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Fluticasone Furoate OD and Placebo BID

Fluticasone Propionate BID and Placebo OD

Placebo only BID

Arm Description

Fluticasone furoate inhalation powder once daily and placebo inhalation powder twice daily for 24 weeks

Fluticasone propionate inhalation powder twice daily and placebo inhalation powder once daily for 24 weeks

Placebo inhalation powder twice daily for 24 weeks

Outcomes

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
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
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
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
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
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
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.

Full Information

First Posted
July 8, 2010
Last Updated
October 9, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01159912
Brief Title
Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 30, 2010 (undefined)
Primary Completion Date
January 1, 2012 (Actual)
Study Completion Date
January 16, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
fluticasone propionate, Fluticasone furoate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluticasone Furoate OD and Placebo BID
Arm Type
Experimental
Arm Description
Fluticasone furoate inhalation powder once daily and placebo inhalation powder twice daily for 24 weeks
Arm Title
Fluticasone Propionate BID and Placebo OD
Arm Type
Active Comparator
Arm Description
Fluticasone propionate inhalation powder twice daily and placebo inhalation powder once daily for 24 weeks
Arm Title
Placebo only BID
Arm Type
Placebo Comparator
Arm Description
Placebo inhalation powder twice daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Intervention Description
Fluticasone propionate inhalation powder, 250 µg
Intervention Type
Drug
Intervention Name(s)
Fluticasone furoate
Intervention Description
Fluticasone furoate inhalation powder, 100 µg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo inhalation powder
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period
Description
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.
Time Frame
Baseline and Week 24
Title
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
Description
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.
Time Frame
From Baseline up to Week 12 and Week 24
Title
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period
Description
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.
Time Frame
From Baseline up to Week 12 and Week 24
Title
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24
Description
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.
Time Frame
Baseline, Week 12, and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
GSK Investigational Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
GSK Investigational Site
City
Green Valley
State/Province
Arizona
ZIP/Postal Code
85614
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Investigational Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
GSK Investigational Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
GSK Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
GSK Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
GSK Investigational Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8415
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
GSK Investigational Site
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
GSK Investigational Site
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
GSK Investigational Site
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
GSK Investigational Site
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
GSK Investigational Site
City
Shiloh
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
GSK Investigational Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
GSK Investigational Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
GSK Investigational Site
City
Sunset
State/Province
Louisiana
ZIP/Postal Code
70584
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
GSK Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123-4303
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
GSK Investigational Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28152
Country
United States
Facility Name
GSK Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
GSK Investigational Site
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
GSK Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
GSK Investigational Site
City
Collegeville
State/Province
Pennsylvania
ZIP/Postal Code
19426
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
GSK Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
GSK Investigational Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
GSK Investigational Site
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
GSK Investigational Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
GSK Investigational Site
City
Gozée
ZIP/Postal Code
6534
Country
Belgium
Facility Name
GSK Investigational Site
City
Halen
ZIP/Postal Code
3544
Country
Belgium
Facility Name
GSK Investigational Site
City
Hamois (Natoye)
ZIP/Postal Code
5360
Country
Belgium
Facility Name
GSK Investigational Site
City
Tremelo
ZIP/Postal Code
3120
Country
Belgium
Facility Name
GSK Investigational Site
City
Ruedersdorf
State/Province
Brandenburg
ZIP/Postal Code
15562
Country
Germany
Facility Name
GSK Investigational Site
City
Schwedt
State/Province
Brandenburg
ZIP/Postal Code
16303
Country
Germany
Facility Name
GSK Investigational Site
City
Eschwege
State/Province
Hessen
ZIP/Postal Code
37269
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30173
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45359
Country
Germany
Facility Name
GSK Investigational Site
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39112
Country
Germany
Facility Name
GSK Investigational Site
City
Erfurt
State/Province
Thueringen
ZIP/Postal Code
99084
Country
Germany
Facility Name
GSK Investigational Site
City
Schmoelln
State/Province
Thueringen
ZIP/Postal Code
04626
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12043
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
GSK Investigational Site
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
GSK Investigational Site
City
Kielce
ZIP/Postal Code
25-751
Country
Poland
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
GSK Investigational Site
City
Lomza
ZIP/Postal Code
18-400
Country
Poland
Facility Name
GSK Investigational Site
City
Sopot
ZIP/Postal Code
81-741
Country
Poland
Facility Name
GSK Investigational Site
City
Szczecin
ZIP/Postal Code
71-124
Country
Poland
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
022102
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
050042
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
050526
Country
Romania
Facility Name
GSK Investigational Site
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
GSK Investigational Site
City
Iasi
ZIP/Postal Code
700115
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
27881132
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112059
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112059
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112059
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112059
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112059
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112059
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112059
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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