A Dose-ranging Study of Fluticasone Furoate (FF)
1 other identifier
interventional
597
15 countries
139
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Mar 2012
Typical duration for phase_2 asthma
139 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2012
CompletedFirst Posted
Study publicly available on registry
March 26, 2012
CompletedStudy Start
First participant enrolled
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2014
CompletedResults Posted
Study results publicly available
April 27, 2015
CompletedMay 30, 2017
April 1, 2017
2.5 years
March 15, 2012
April 9, 2015
April 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline; Week 1 up to Week 12
Secondary Outcomes (7)
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
Baseline, Week 12
Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 12-week Treatment Period
Baseline; Week 1 up to Week 12
Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period
Baseline; Week 1 up to Week 12
Change From Baseline in PM PEF Over the Last 7 Days of the Treatment Period (Week 12)
Baseline; Week 12
Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 12)
Baseline; Week 12
- +2 more secondary outcomes
Study Arms (5)
Arm 1
ACTIVE COMPARATORFluticasone Furoate 100mcg inhalation powder once daily in the evening ICS powder
Arm 2
ACTIVE COMPARATORFluticasone Furoate 50mcg inhalation powder once daily in the evening ICS powder
Arm 3
ACTIVE COMPARATORFluticasone Furoate 25mcg inhalation powder once daily in the evening ics powder
Arm 4
ACTIVE COMPARATORFluticasone Propionate 100mcg inhalation powder twice daily ICS powder
Arm 5
PLACEBO COMPARATORPlacebo inhalation powder once daily in the evening Placebo powder
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (139)
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Costa Mesa, California, 92626, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Cocoa, Florida, 32927, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Eagle, Idaho, 83616, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
GSK Investigational Site
Shiloh, Illinois, 62269, United States
GSK Investigational Site
Lenexa, Kansas, 66215, United States
GSK Investigational Site
Owensboro, Kentucky, 42301, United States
GSK Investigational Site
Stevensville, Michigan, 49127, United States
GSK Investigational Site
Plymouth, Minnesota, 55441, United States
GSK Investigational Site
Columbia, Missouri, 65203, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
Corning, New York, 14830, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97202, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Austin, Texas, 78750, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Plovdiv, 4002, Bulgaria
GSK Investigational Site
Plovdiv, 4003, Bulgaria
GSK Investigational Site
Rousse, 7000, Bulgaria
GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Tbilisi, 0119, Georgia
GSK Investigational Site
Tbilisi, 0159, Georgia
GSK Investigational Site
Tbilisi, 0160, Georgia
GSK Investigational Site
Tbilisi, 0186, Georgia
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68163, Germany
GSK Investigational Site
Berchtesgaden, Bavaria, 83471, Germany
GSK Investigational Site
Rosenheim, Bavaria, 83026, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Neu-Isenburg, Hesse, 63263, Germany
GSK Investigational Site
Niedernhausen, Hesse, 65527, Germany
GSK Investigational Site
Göttingen, Lower Saxony, 37073, Germany
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791, Germany
GSK Investigational Site
Hamm, North Rhine-Westphalia, 59063, Germany
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533, Germany
GSK Investigational Site
Telgte, North Rhine-Westphalia, 48291, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724, Germany
GSK Investigational Site
Berlin, 10785, Germany
GSK Investigational Site
Hamburg, 22415, Germany
GSK Investigational Site
Chiba, 260-0001, Japan
GSK Investigational Site
Fukuoka, 811-1394, Japan
GSK Investigational Site
Hiroshima, 720-8520, Japan
GSK Investigational Site
Hokkaido, 006-0831, Japan
GSK Investigational Site
Hokkaido, 064-0821, Japan
GSK Investigational Site
Hyōgo, 653-0021, Japan
GSK Investigational Site
Kagawa, 762-0031, Japan
GSK Investigational Site
Mie, 514-0125, Japan
GSK Investigational Site
Osaka, 583-8588, Japan
GSK Investigational Site
Tokyo, 154-0017, Japan
GSK Investigational Site
Tokyo, 157-0066, Japan
GSK Investigational Site
Tokyo, 158-0097, Japan
GSK Investigational Site
Wakayama, 646-8558, Japan
GSK Investigational Site
Daugavpils, LV5403, Latvia
GSK Investigational Site
Rēzekne, LV-4601, Latvia
GSK Investigational Site
Riga, LV 1003, Latvia
GSK Investigational Site
Riga, LV 1004, Latvia
GSK Investigational Site
Riga, LV1011, Latvia
GSK Investigational Site
Guadalajara, Jalisco, 44100, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45040, Mexico
GSK Investigational Site
Morelia, Michoacán, 58070, Mexico
GSK Investigational Site
Villahermosa, Tabasco, 86100, Mexico
GSK Investigational Site
Mexico City, 06720, Mexico
GSK Investigational Site
Mexico City, 07760, Mexico
GSK Investigational Site
México, 04530, Mexico
GSK Investigational Site
Lima, Lima Province, Lima 27, Peru
GSK Investigational Site
Lima, Lima Province, Peru
GSK Investigational Site
San Borja, Lima region, Lima 41, Peru
GSK Investigational Site
San Miguel, Lima region, Lima 32, Peru
GSK Investigational Site
Lima, Lima 11, Peru
GSK Investigational Site
Lima, Lima 27, Peru
GSK Investigational Site
Lima, Lima 29, Peru
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Manila, 1003, Philippines
GSK Investigational Site
Quezon City, 1113, Philippines
GSK Investigational Site
Bialystok, 15-183, Poland
GSK Investigational Site
Bialystok, 15-430, Poland
GSK Investigational Site
Bydgoszcz, 85-046, Poland
GSK Investigational Site
Dębica, 39-200, Poland
GSK Investigational Site
Kielce, 25-017, Poland
GSK Investigational Site
Lodz, 93-513, Poland
GSK Investigational Site
Lublin, 20-089, Poland
GSK Investigational Site
Lublin, 20-093, Poland
GSK Investigational Site
Lublin, 20-552, Poland
GSK Investigational Site
Poznan, 60-693, Poland
GSK Investigational Site
Tarnów, 33-100, Poland
GSK Investigational Site
Hato Rey, Puerto Rico, 00917, Puerto Rico
GSK Investigational Site
Blagoveshchensk, 675000, Russia
GSK Investigational Site
Moscow, 119991, Russia
GSK Investigational Site
Murmansk, 183031, Russia
GSK Investigational Site
Novokuznetsk, 654063, Russia
GSK Investigational Site
Novosibirsk, 630091, Russia
GSK Investigational Site
Saint Petersburg, 194356, Russia
GSK Investigational Site
Voronezh, 394036, Russia
GSK Investigational Site
Yaroslavl, 150003, Russia
GSK Investigational Site
Panorama, Western Province, 7500, South Africa
GSK Investigational Site
CapeTown, 7764, South Africa
GSK Investigational Site
Middelburg, 1501, South Africa
GSK Investigational Site
Gothenburg, SE-416 85, Sweden
GSK Investigational Site
Kungsbacka, SE-434 30, Sweden
GSK Investigational Site
Örebro, SE-701 85, Sweden
GSK Investigational Site
Stockholm, SE-118 83, Sweden
GSK Investigational Site
Stockholm, SE171 76, Sweden
GSK Investigational Site
Uppsala, SE-752 26, Sweden
GSK Investigational Site
Visby, SE-621 84, Sweden
GSK Investigational Site
Chernivtsi, 58001, Ukraine
GSK Investigational Site
Ivano-Frankivsk, 76018, Ukraine
GSK Investigational Site
Kharkiv, 61093, Ukraine
GSK Investigational Site
Kherson, 73000, Ukraine
GSK Investigational Site
Kyiv, 03680, Ukraine
GSK Investigational Site
Kyiv, 04050, Ukraine
GSK Investigational Site
Luhansk, 91000, Ukraine
GSK Investigational Site
Simferopol, 95034, Ukraine
GSK Investigational Site
Vinnytsia, 21021, Ukraine
GSK Investigational Site
Yevpatoriia, 97408, Ukraine
GSK Investigational Site
Zaporizhia, 69063, Ukraine
GSK Investigational Site
Zaporizhia, 69076, Ukraine
Related Publications (1)
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.
PMID: 27622699DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2012
First Posted
March 26, 2012
Study Start
March 28, 2012
Primary Completion
September 24, 2014
Study Completion
September 24, 2014
Last Updated
May 30, 2017
Results First Posted
April 27, 2015
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.