AsthmaPhase 2NCT01563029

A Dose-ranging Study of Fluticasone Furoate (FF)

A Phase 2 study testing Fluticasone Furoate and Fluticasone Propionate in people with Asthma, run by GlaxoSmithKline at 139 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 5 to 11 years
Conditions the study is for: Asthma
What is being tested?: Fluticasone Furoate and Fluticasone Propionate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 597 participants
Where: 139 sitesin 15 countries
Study dates: 28 Mar 2012to 24 Sep 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

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 :

Who cannot join

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

Trial locations and contacts

139 sites in 15 countries.

Country

City, postcode or hospital

139 sites in 15 countries

United States37 sites

GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Cocoa, Florida, 32927
GSK Investigational Site
Columbia, Missouri, 65203
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Corning, New York, 14830
GSK Investigational Site
Costa Mesa, California, 92626
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Eagle, Idaho, 83616
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Lenexa, Kansas, 66215
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
Normal, Illinois, 61761
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Owensboro, Kentucky, 42301
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Plymouth, Minnesota, 55441
GSK Investigational Site
Portland, Oregon, 97202
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Antonio, Texas, 78258
GSK Investigational Site
Shiloh, Illinois, 62269
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
Waco, Texas, 76712

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Germany17 sites

GSK Investigational Site
Berchtesgaden, Bavaria, 83471
GSK Investigational Site
Berlin, 10785
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502
GSK Investigational Site
Göttingen, Lower Saxony, 37073
GSK Investigational Site
Hamburg, 22415
GSK Investigational Site
Hamm, North Rhine-Westphalia, 59063
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68163
GSK Investigational Site
Neu-Isenburg, Hesse, 63263
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724
GSK Investigational Site
Niedernhausen, Hesse, 65527
GSK Investigational Site
Rosenheim, Bavaria, 83026
GSK Investigational Site
Telgte, North Rhine-Westphalia, 48291
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302

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Japan13 sites

GSK Investigational Site
Chiba, 260-0001
GSK Investigational Site
Fukuoka, 811-1394
GSK Investigational Site
Hiroshima, 720-8520
GSK Investigational Site
Hokkaido, 006-0831
GSK Investigational Site
Hokkaido, 064-0821
GSK Investigational Site
Hyōgo, 653-0021
GSK Investigational Site
Kagawa, 762-0031
GSK Investigational Site
Mie, 514-0125
GSK Investigational Site
Osaka, 583-8588
GSK Investigational Site
Tokyo, 154-0017
GSK Investigational Site
Tokyo, 157-0066
GSK Investigational Site
Tokyo, 158-0097
GSK Investigational Site
Wakayama, 646-8558

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Ukraine12 sites

GSK Investigational Site
Chernivtsi, 58001
GSK Investigational Site
Ivano-Frankivsk, 76018
GSK Investigational Site
Kharkiv, 61093
GSK Investigational Site
Kherson, 73000
GSK Investigational Site
Kyiv, 03680
GSK Investigational Site
Kyiv, 04050
GSK Investigational Site
Luhansk, 91000
GSK Investigational Site
Simferopol, 95034
GSK Investigational Site
Vinnytsia, 21021
GSK Investigational Site
Yevpatoriia, 97408
GSK Investigational Site
Zaporizhia, 69063
GSK Investigational Site
Zaporizhia, 69076

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Poland11 sites

GSK Investigational Site
Bialystok, 15-183
GSK Investigational Site
Bialystok, 15-430
GSK Investigational Site
Bydgoszcz, 85-046
GSK Investigational Site
Dębica, 39-200
GSK Investigational Site
Kielce, 25-017
GSK Investigational Site
Lodz, 93-513
GSK Investigational Site
Lublin, 20-089
GSK Investigational Site
Lublin, 20-093
GSK Investigational Site
Lublin, 20-552
GSK Investigational Site
Poznan, 60-693
GSK Investigational Site
Tarnów, 33-100

Other trials in Poland

Russia8 sites

GSK Investigational Site
Blagoveshchensk, 675000
GSK Investigational Site
Moscow, 119991
GSK Investigational Site
Murmansk, 183031
GSK Investigational Site
Novokuznetsk, 654063
GSK Investigational Site
Novosibirsk, 630091
GSK Investigational Site
Saint Petersburg, 194356
GSK Investigational Site
Voronezh, 394036
GSK Investigational Site
Yaroslavl, 150003

Other trials in Russia

Mexico7 sites

GSK Investigational Site
Guadalajara, Jalisco, 44100
GSK Investigational Site
México, 04530
GSK Investigational Site
Mexico City, 06720
GSK Investigational Site
Mexico City, 07760
GSK Investigational Site
Morelia, Michoacán, 58070
GSK Investigational Site
Villahermosa, Tabasco, 86100
GSK Investigational Site
Zapopan, Jalisco, 45040

Other trials in Mexico

Peru7 sites

GSK Investigational Site
Lima, Lima Province, Lima 27
GSK Investigational Site
Lima, Lima Province
GSK Investigational Site
Lima, Lima 11
GSK Investigational Site
Lima, Lima 27
GSK Investigational Site
Lima, Lima 29
GSK Investigational Site
San Borja, Lima region, Lima 41
GSK Investigational Site
San Miguel, Lima region, Lima 32

Other trials in Peru

Sweden7 sites

GSK Investigational Site
Gothenburg, SE-416 85
GSK Investigational Site
Kungsbacka, SE-434 30
GSK Investigational Site
Örebro, SE-701 85
GSK Investigational Site
Stockholm, SE-118 83
GSK Investigational Site
Stockholm, SE171 76
GSK Investigational Site
Uppsala, SE-752 26
GSK Investigational Site
Visby, SE-621 84

Other trials in Sweden

Latvia5 sites

GSK Investigational Site
Daugavpils, LV5403
GSK Investigational Site
Rēzekne, LV-4601
GSK Investigational Site
Riga, LV 1003
GSK Investigational Site
Riga, LV 1004
GSK Investigational Site
Riga, LV1011

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Bulgaria4 sites

GSK Investigational Site
Plovdiv, 4002
GSK Investigational Site
Plovdiv, 4003
GSK Investigational Site
Rousse, 7000
GSK Investigational Site
Sofia

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Georgia4 sites

GSK Investigational Site
Tbilisi, 0119
GSK Investigational Site
Tbilisi, 0159
GSK Investigational Site
Tbilisi, 0160
GSK Investigational Site
Tbilisi, 0186

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Philippines3 sites

GSK Investigational Site
Manila, 1000
GSK Investigational Site
Manila, 1003
GSK Investigational Site
Quezon City, 1113

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South Africa3 sites

GSK Investigational Site
CapeTown, 7764
GSK Investigational Site
Middelburg, 1501
GSK Investigational Site
Panorama, Western Province, 7500

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Puerto Rico1 site

GSK Investigational Site
Hato Rey, Puerto Rico, 00917

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About this study

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

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.

Conditions: Asthma
Being tested: Fluticasone Furoate, Fluticasone Propionate, Placebo
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluticasone FuroateDrug
current asthma medicine
Fluticasone PropionateDrug
Fluticasone propionate
PlaceboDrug
placebo

Study groups in NCT01563029
Study group	Role	What they receive
Arm 1	Active comparator	Fluticasone Furoate 100mcg inhalation powder once daily in the evening ICS powder Receives: Drug: Fluticasone Furoate
Arm 2	Active comparator	Fluticasone Furoate 50mcg inhalation powder once daily in the evening ICS powder Receives: Drug: Fluticasone Furoate
Arm 3	Active comparator	Fluticasone Furoate 25mcg inhalation powder once daily in the evening ics powder Receives: Drug: Fluticasone Furoate
Arm 4	Active comparator	Fluticasone Propionate 100mcg inhalation powder twice daily ICS powder Receives: Drug: Fluticasone Propionate
Arm 5	Placebo comparator	Placebo inhalation powder once daily in the evening Placebo powder Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: Baseline, Week 12
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.
Measured: Baseline; Week 1 up to Week 12
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.
Measured: Baseline; Week 1 up to Week 12
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.
Measured: Baseline; Week 12
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.
Measured: Baseline; Week 12
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.
Measured: Baseline; Week 1 up to Week 12
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.
Measured: Up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 201224 Sep 2014

First posted26 Mar 2012 (estimated)
Study start28 Mar 2012
Primary completion24 Sep 2014
Study completion24 Sep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 597 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01563029
Sponsor's protocol ID: 106855
Status last verified: Apr 2017
First submitted: 15 Mar 2012
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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.
PubMed 27622699

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-ranging Study of Fluticasone Furoate (FF) Inhalation Powder in Children Aged 5-11 Years With Asthma
ClinicalTrials.gov ID: NCT01563029
Acronym / sponsor ID: 106855
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 597 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Mar 2012 (actual)
Primary completion: 24 Sep 2014 (actual)
Study completion: 24 Sep 2014 (actual)
First posted: 26 Mar 2012 (estimated)
Results: Posted 27 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Arm 1	Active comparator	Drug: Fluticasone FuroateFluticasone Furoate 100mcg inhalation powder once daily in the evening ICS powder
Arm 2	Active comparator	Drug: Fluticasone FuroateFluticasone Furoate 50mcg inhalation powder once daily in the evening ICS powder
Arm 3	Active comparator	Drug: Fluticasone FuroateFluticasone Furoate 25mcg inhalation powder once daily in the evening ics powder
Arm 4	Active comparator	Drug: Fluticasone PropionateFluticasone Propionate 100mcg inhalation powder twice daily ICS powder
Arm 5	Placebo comparator	Drug: PlaceboPlacebo inhalation powder once daily in the evening Placebo powder

Who may qualify

Ages: 5 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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 :

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluticasone Furoatecurrent asthma medicine	Drug	Arm 1, Arm 2, Arm 3
Fluticasone PropionateFluticasone propionate	Drug	Arm 4
Placeboplacebo	Drug	Arm 5

Primary outcome

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
Time frame: Baseline; Week 1 up to 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 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.

7 secondary outcomes

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
Time frame: Baseline, Week 12
Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 12-week Treatment Period
Time frame: Baseline; Week 1 up to Week 12
Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period
Time frame: Baseline; Week 1 up to Week 12
Change From Baseline in PM PEF Over the Last 7 Days of the Treatment Period (Week 12)
Time frame: Baseline; Week 12
Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 12)
Time frame: Baseline; Week 12
Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 12-week Treatment Period
Time frame: Baseline; Week 1 up to Week 12
Number of Withdrawals Due to Lack of Efficacy Throughout the 12-week Treatment Period
Time frame: Up to Week 12

Results and safety

Results posted to the registry on 27 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	119	66
FF 25 µg OD	118	94
FF 50 µg OD	120	87
FF 100 µg OD	118	85
FP 100 µg BID	118	89

Primary outcome: 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

Time frame: Baseline; Week 1 up to Week 12. Least squares mean (Standard Deviation). Unit: Liters per minute (L/min)

Measure	Placebo n = 119	FF 25 µg OD n = 117	FF 50 µg OD n = 118	FF 100 µg OD n = 118	FP 100 µg BID n = 117	Average of FF 50 µg OD and FF 100 µg OD n = 236
Value	3.3 (2.63)	21.9 (2.66)	22.8 (2.65)	15.8 (2.64)	17.3 (2.64)	19.3 (1.86)

Placebo vs Average of FF 50 µg OD and FF 100 µg OD: Mean Difference (Final Values): 16.0 (95% CI 9.6 to 22.4), p <0.001, ANCOVA
Placebo vs FF 100 µg OD: Mean Difference (Final Values): 12.5 (95% CI 5.1 to 19.8), p <0.001, ANCOVA
Placebo vs FF 50 µg OD: Mean Difference (Final Values): 19.5 (95% CI 12.1 to 26.9), p <0.001, ANCOVA

Population analysed: ITT Population: participants randomized to treatment who received at least 1 dose of study medication. Only participants available at the specified time points were analyzed.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 13 weeks).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 119 (0%)	20 of 119 (16.8%)	Not reported
FF 25 µg OD	0 of 118 (0%)	27 of 118 (22.9%)	Not reported
FF 50 µg OD	1 of 120 (0.8%)	20 of 120 (16.7%)	Not reported
FF 100 µg OD	1 of 118 (0.8%)	29 of 118 (24.6%)	Not reported
FP 100 µg BID	0 of 118 (0%)	24 of 118 (20.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27622699Oliver 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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

139 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluticasone Furoate and Fluticasone Propionate in people with Asthma, run by GlaxoSmithKline at 139 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Germany, Japan, Ukraine, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline; Week 1 up to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01563029, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.