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A Dose-ranging Study of Fluticasone Furoate (FF)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Fluticasone Furoate

Fluticasone Propionate

Placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent from at least one parent/ legal guardian to take part in the study.:
Diagnosis of asthma
pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
Receiving therapy of short acting beta-agonist (SABA) alone, LTM, or ICS (total daily dose <FP 200mcg or equivalent)Exclusion :

Exclusion Criteria:

history of life-threatening asthma
history of asthma exacerbation for asthma within 6 months prior to screening.
Culture-documented or suspected bacterial or viral infection
significant abnormality or medical condition
Present use of any tobacco products

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Description

Fluticasone Furoate 100mcg inhalation powder once daily in the evening ICS powder

Fluticasone Furoate 50mcg inhalation powder once daily in the evening ICS powder

Fluticasone Furoate 25mcg inhalation powder once daily in the evening ics powder

Fluticasone Propionate 100mcg inhalation powder twice daily ICS powder

Placebo inhalation powder once daily in the evening Placebo powder

Outcomes

Primary Outcome Measures

Change From Baseline in Daily Pre-dose Morning (AM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 12-week Treatment Period

PEF 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 prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline AM PEF, actual pre-screening inhaled corticosteroid (ICS) use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.

Secondary Outcome Measures

Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period in Children Who Could Perform the Maneuver

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 a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, actual pre-screening ICS use, 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. Only those participants available at the specified time points were analyzed.

Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 12-week Treatment Period

The number of inhalations of rescue albuterol/salbutamol aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. The Baseline rescue-free value was defined as the percentage of rescue-free 24-hr periods from the last 7 days of the Run-in Period. Change from Baseline was calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment.

Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period

PEF 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 evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period (at Week 12) minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.

Change From Baseline in PM PEF Over the Last 7 Days of the Treatment Period (Week 12)

PEF 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 evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in PM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.

Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 12)

PEF 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 evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in AM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.

Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 12-week Treatment Period

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 PEF measurement. A 24-hour (hr) 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 symptom-free value is defined as the percentage of symptom free 24-hr periods in the last 7 days of the run-in period. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment group.

Number of Withdrawals Due to Lack of Efficacy Throughout the 12-week Treatment Period

The number of participants whose primary reason for withdrawal from the study was due to lack of efficacy is presented together with p-values for the treatment comparisons.

Full Information

NCT ID

NCT01563029

First Posted

March 15, 2012

Last Updated

April 25, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01563029

Brief Title

A Dose-ranging Study of Fluticasone Furoate (FF)

Official Title

A Dose-ranging Study of Fluticasone Furoate (FF) Inhalation Powder in Children Aged 5-11 Years With Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

March 28, 2012 (Actual)

Primary Completion Date

September 24, 2014 (Actual)

Study Completion Date

September 24, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy, parallel-group, placebo and active controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period during which time they will continue their current medications. Visit 2 will occur two weeks into the run-in period to allow a review of compliance with daily diary and run-in medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility criteria who remain uncontrolled despite baseline therapy will be stratified based on pre screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to the treatment phase of the study where they will receive one of five treatments for 12 weeks. Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of 115 randomized/evaluable subjects per treatment arm. Subjects will attend on-treatment visits at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up contact will be performed one week after completing study medication. All subjects must attempt spirometry measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine collection for urinary cortisol and creatinine excretion will be performed prior to randomization at Visit 2 and within 7 days prior to Visit 7. All subjects must perform PEF daily between visits 1 and 7. The primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) PM PEF from patient hand held electronic daily diary at Endpoint (Endpoint is defined as the mean over the last 7 days of treatment). Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, urinary cortisol, and vital signs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

597 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Description

Fluticasone Furoate 100mcg inhalation powder once daily in the evening ICS powder

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

Fluticasone Furoate 50mcg inhalation powder once daily in the evening ICS powder

Arm Title

Arm 3

Arm Type

Active Comparator

Arm Description

Fluticasone Furoate 25mcg inhalation powder once daily in the evening ics powder

Arm Title

Arm 4

Arm Type

Active Comparator

Arm Description

Fluticasone Propionate 100mcg inhalation powder twice daily ICS powder

Arm Title

Arm 5

Arm Type

Placebo Comparator

Arm Description

Placebo inhalation powder once daily in the evening Placebo powder

Intervention Type

Drug

Intervention Name(s)

Fluticasone Furoate

Intervention Description

current asthma medicine

Intervention Type

Drug

Intervention Name(s)

Fluticasone Propionate

Intervention Description

Fluticasone propionate

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Change From Baseline in Daily Pre-dose Morning (AM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 12-week Treatment Period

Description

Time Frame

Baseline; Week 1 up to Week 12

Secondary Outcome Measure Information:

Title

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 12-week Treatment Period

Description

Time Frame

Baseline; Week 1 up to Week 12

Title

Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period

Description

PEF 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 evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period (at Week 12) minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.

Time Frame

Baseline; Week 1 up to Week 12

Title

Change From Baseline in PM PEF Over the Last 7 Days of the Treatment Period (Week 12)

Description

PEF 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 evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in PM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.

Time Frame

Baseline; Week 12

Title

Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 12)

Description

PEF 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 evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in AM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.

Time Frame

Baseline; Week 12

Title

Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 12-week Treatment Period

Description

Time Frame

Baseline; Week 1 up to Week 12

Title

Number of Withdrawals Due to Lack of Efficacy Throughout the 12-week Treatment Period

Description

The number of participants whose primary reason for withdrawal from the study was due to lack of efficacy is presented together with p-values for the treatment comparisons.

Time Frame

Up to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent from at least one parent/ legal guardian to take part in the study.: Diagnosis of asthma pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value Receiving therapy of short acting beta-agonist (SABA) alone, LTM, or ICS (total daily dose <FP 200mcg or equivalent)Exclusion : Exclusion Criteria: history of life-threatening asthma history of asthma exacerbation for asthma within 6 months prior to screening. Culture-documented or suspected bacterial or viral infection significant abnormality or medical condition Present use of any tobacco products

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

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

GSK Investigational Site

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

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

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

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

GSK Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

GSK Investigational Site

City

Cocoa

State/Province

Florida

ZIP/Postal Code

32927

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

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

Eagle

State/Province

Idaho

ZIP/Postal Code

83616

Country

United States

Facility Name

GSK Investigational Site

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

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

Stevensville

State/Province

Michigan

ZIP/Postal Code

49127

Country

United States

Facility Name

GSK Investigational Site

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55441

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

Rolla

State/Province

Missouri

ZIP/Postal Code

65401

Country

United States

Facility Name

GSK Investigational Site

City

Corning

State/Province

New York

ZIP/Postal Code

14830

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

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

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

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

Portland

State/Province

Oregon

ZIP/Postal Code

97202

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

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

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

75230

Country

United States

Facility Name

GSK Investigational Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79925

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

78258

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

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4003

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Tbilisi

ZIP/Postal Code

0119

Country

Georgia

Facility Name

GSK Investigational Site

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

GSK Investigational Site

City

Tbilisi

ZIP/Postal Code

0160

Country

Georgia

Facility Name

GSK Investigational Site

City

Tbilisi

ZIP/Postal Code

0186

Country

Georgia

Facility Name

GSK Investigational Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68163

Country

Germany

Facility Name

GSK Investigational Site

City

Berchtesgaden

State/Province

Bayern

ZIP/Postal Code

83471

Country

Germany

Facility Name

GSK Investigational Site

City

Rosenheim

State/Province

Bayern

ZIP/Postal Code

83026

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60596

Country

Germany

Facility Name

GSK Investigational Site

City

Neu isenburg

State/Province

Hessen

ZIP/Postal Code

63263

Country

Germany

Facility Name

GSK Investigational Site

City

Niedernhausen

State/Province

Hessen

ZIP/Postal Code

65527

Country

Germany

Facility Name

GSK Investigational Site

City

Goettingen

State/Province

Niedersachsen

ZIP/Postal Code

37073

Country

Germany

Facility Name

GSK Investigational Site

City

Wolfenbuettel

State/Province

Niedersachsen

ZIP/Postal Code

38302

Country

Germany

Facility Name

GSK Investigational Site

City

Bochum

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44791

Country

Germany

Facility Name

GSK Investigational Site

City

Hamm

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

59063

Country

Germany

Facility Name

GSK Investigational Site

City

Kleve-Materborn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47533

Country

Germany

Facility Name

GSK Investigational Site

City

Telgte

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48291

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

GSK Investigational Site

City

Geesthacht

State/Province

Schleswig-Holstein

ZIP/Postal Code

21502

Country

Germany

Facility Name

GSK Investigational Site

City

Neuhaus am Rennweg

State/Province

Thueringen

ZIP/Postal Code

98724

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10785

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

260-0001

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

720-8520

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

006-0831

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

064-0821

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

653-0021

Country

Japan

Facility Name

GSK Investigational Site

City

Kagawa

ZIP/Postal Code

762-0031

Country

Japan

Facility Name

GSK Investigational Site

City

Mie

ZIP/Postal Code

514-0125

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

583-8588

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

154-0017

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

157-0066

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

158-0097

Country

Japan

Facility Name

GSK Investigational Site

City

Wakayama

ZIP/Postal Code

646-8558

Country

Japan

Facility Name

GSK Investigational Site

City

Daugavpils

ZIP/Postal Code

LV5403

Country

Latvia

Facility Name

GSK Investigational Site

City

Rezekne

ZIP/Postal Code

LV-4601

Country

Latvia

Facility Name

GSK Investigational Site

City

Riga

ZIP/Postal Code

LV 1003

Country

Latvia

Facility Name

GSK Investigational Site

City

Riga

ZIP/Postal Code

LV 1004

Country

Latvia

Facility Name

GSK Investigational Site

City

Riga

ZIP/Postal Code

LV1011

Country

Latvia

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44100

Country

Mexico

Facility Name

GSK Investigational Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45040

Country

Mexico

Facility Name

GSK Investigational Site

City

Morelia

State/Province

Michoacán

ZIP/Postal Code

58070

Country

Mexico

Facility Name

GSK Investigational Site

City

Villahermosa

State/Province

Tabasco

ZIP/Postal Code

86100

Country

Mexico

Facility Name

GSK Investigational Site

City

Ciudad de México

ZIP/Postal Code

06720

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico City

ZIP/Postal Code

07760

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico

ZIP/Postal Code

04530

Country

Mexico

Facility Name

GSK Investigational Site

City

Lima 18

State/Province

Lima

Country

Peru

Facility Name

GSK Investigational Site

City

Lima 27

State/Province

Lima

ZIP/Postal Code

Lima 27

Country

Peru

Facility Name

GSK Investigational Site

City

San Borja

State/Province

Lima

ZIP/Postal Code

Lima 41

Country

Peru

Facility Name

GSK Investigational Site

City

San Miguel

State/Province

Lima

ZIP/Postal Code

Lima 32

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Lima 11

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Lima 27

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Lima 29

Country

Peru

Facility Name

GSK Investigational Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

GSK Investigational Site

City

Manila

ZIP/Postal Code

1003

Country

Philippines

Facility Name

GSK Investigational Site

City

Quezon City

ZIP/Postal Code

1113

Country

Philippines

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-183

Country

Poland

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-430

Country

Poland

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-046

Country

Poland

Facility Name

GSK Investigational Site

City

Debica

ZIP/Postal Code

39-200

Country

Poland

Facility Name

GSK Investigational Site

City

Kielce

ZIP/Postal Code

25-017

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-089

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-552

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

GSK Investigational Site

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

GSK Investigational Site

City

Hato Rey

ZIP/Postal Code

00917

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

Blagoveshchensk

ZIP/Postal Code

675000

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Murmansk

ZIP/Postal Code

183031

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novokuznetsk

ZIP/Postal Code

654063

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

194356

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Voronezh

ZIP/Postal Code

394036

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Panorama

State/Province

Western Province

ZIP/Postal Code

7500

Country

South Africa

Facility Name

GSK Investigational Site

City

CapeTown

ZIP/Postal Code

7764

Country

South Africa

Facility Name

GSK Investigational Site

City

Middelburg

ZIP/Postal Code

1501

Country

South Africa

Facility Name

GSK Investigational Site

City

Göteborg

ZIP/Postal Code

SE-416 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Kungsbacka

ZIP/Postal Code

SE-434 30

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-118 83

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE171 76

Country

Sweden

Facility Name

GSK Investigational Site

City

Uppsala

ZIP/Postal Code

SE-752 26

Country

Sweden

Facility Name

GSK Investigational Site

City

Visby

ZIP/Postal Code

SE-621 84

Country

Sweden

Facility Name

GSK Investigational Site

City

Örebro

ZIP/Postal Code

SE-701 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Chernivtsi

ZIP/Postal Code

58001

Country

Ukraine

Facility Name

GSK Investigational Site

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61093

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kherson

ZIP/Postal Code

73000

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

GSK Investigational Site

City

Luhansk

ZIP/Postal Code

91000

Country

Ukraine

Facility Name

GSK Investigational Site

City

Simferopol

ZIP/Postal Code

95034

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnytsia

ZIP/Postal Code

21021

Country

Ukraine

Facility Name

GSK Investigational Site

City

Yevpatoriia

ZIP/Postal Code

97408

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zaporizhia

ZIP/Postal Code

69063

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zaporizhia

ZIP/Postal Code

69076

Country

Ukraine

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

27622699

Citation

Oliver AJ, Covar RA, Goldfrad CH, Klein RM, Pedersen SE, Sorkness CA, Tomkins SA, Villaran C, Grigg J. Randomized Trial of Once-Daily Fluticasone Furoate in Children with Inadequately Controlled Asthma. J Pediatr. 2016 Nov;178:246-253.e2. doi: 10.1016/j.jpeds.2016.08.010. Epub 2016 Sep 9.

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

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106855

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

106855

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

106855

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

106855

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

106855

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106855

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

106855

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Dose-ranging Study of Fluticasone Furoate (FF)

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A Dose-ranging Study of Fluticasone Furoate (FF)

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial