A Dose-ranging Study of Fluticasone Furoate (FF)

NCT ID: NCT01563029

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 597 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-28
• Study Completion Date: 2014-09-24

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

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

Group Type: ACTIVE_COMPARATOR

Fluticasone Furoate

Intervention Type: DRUG

current asthma medicine

Arm 2

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

Group Type: ACTIVE_COMPARATOR

Fluticasone Furoate

Intervention Type: DRUG

current asthma medicine

Arm 3

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

Group Type: ACTIVE_COMPARATOR

Fluticasone Furoate

Intervention Type: DRUG

current asthma medicine

Arm 4

Fluticasone Propionate 100mcg inhalation powder twice daily ICS powder

Group Type: ACTIVE_COMPARATOR

Fluticasone Propionate

Intervention Type: DRUG

Fluticasone propionate

Arm 5

Placebo inhalation powder once daily in the evening Placebo powder

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

Fluticasone Furoate

current asthma medicine

Intervention Type: DRUG

Fluticasone Propionate

Fluticasone propionate

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Costa Mesa, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Orange, California, United States

GSK Investigational Site

Rolling Hills Estates, California, United States

GSK Investigational Site

Aventura, Florida, United States

GSK Investigational Site

Cocoa, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Columbus, Georgia, United States

GSK Investigational Site

Eagle, Idaho, United States

GSK Investigational Site

Normal, Illinois, United States

GSK Investigational Site

Shiloh, Illinois, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Owensboro, Kentucky, United States

GSK Investigational Site

Stevensville, Michigan, United States

GSK Investigational Site

Plymouth, Minnesota, United States

GSK Investigational Site

Columbia, Missouri, United States

GSK Investigational Site

Rolla, Missouri, United States

GSK Investigational Site

Corning, New York, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Canton, Ohio, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Orangeburg, South Carolina, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

El Paso, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Waco, Texas, United States

GSK Investigational Site

South Burlington, Vermont, United States

GSK Investigational Site

Plovdiv, , Bulgaria

GSK Investigational Site

Plovdiv, , Bulgaria

GSK Investigational Site

Rousse, , Bulgaria

GSK Investigational Site

Sofia, , Bulgaria

GSK Investigational Site

Tbilisi, , Georgia

GSK Investigational Site

Tbilisi, , Georgia

GSK Investigational Site

Tbilisi, , Georgia

GSK Investigational Site

Tbilisi, , Georgia

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Berchtesgaden, Bavaria, Germany

GSK Investigational Site

Rosenheim, Bavaria, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Neu-Isenburg, Hesse, Germany

GSK Investigational Site

Niedernhausen, Hesse, Germany

GSK Investigational Site

Göttingen, Lower Saxony, Germany

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Hamm, North Rhine-Westphalia, Germany

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

GSK Investigational Site

Telgte, North Rhine-Westphalia, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Geesthacht, Schleswig-Holstein, Germany

GSK Investigational Site

Neuhaus am Rennweg, Thuringia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Chiba, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Kagawa, , Japan

GSK Investigational Site

Mie, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Wakayama, , Japan

GSK Investigational Site

Daugavpils, , Latvia

GSK Investigational Site

Rēzekne, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Guadalajara, Jalisco, Mexico

GSK Investigational Site

Zapopan, Jalisco, Mexico

GSK Investigational Site

Morelia, Michoacán, Mexico

GSK Investigational Site

Villahermosa, Tabasco, Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

México, , Mexico

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

San Borja, Lima region, Peru

GSK Investigational Site

San Miguel, Lima region, Peru

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Bialystok, , Poland

GSK Investigational Site

Bialystok, , Poland

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Kielce, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Tarnów, , Poland

GSK Investigational Site

Hato Rey, Puerto Rico, Puerto Rico

GSK Investigational Site

Blagoveshchensk, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Murmansk, , Russia

GSK Investigational Site

Novokuznetsk, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Voronezh, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Panorama, Western Province, South Africa

GSK Investigational Site

CapeTown, , South Africa

GSK Investigational Site

Middelburg, , South Africa

GSK Investigational Site

Gothenburg, , Sweden

GSK Investigational Site

Kungsbacka, , Sweden

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Stockholm, , Sweden

GSK Investigational Site

Stockholm, , Sweden

GSK Investigational Site

Uppsala, , Sweden

GSK Investigational Site

Visby, , Sweden

GSK Investigational Site

Chernivtsi, , Ukraine

GSK Investigational Site

Ivano-Frankivsk, , Ukraine

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kherson, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Luhansk, , Ukraine

GSK Investigational Site

Simferopol, , Ukraine

GSK Investigational Site

Vinnytsia, , Ukraine

GSK Investigational Site

Yevpatoriia, , Ukraine

GSK Investigational Site

Zaporizhia, , Ukraine

GSK Investigational Site

Zaporizhia, , Ukraine

Countries

United States; Bulgaria; Georgia; Germany; Japan; Latvia; Mexico; Peru; Philippines; Poland; Puerto Rico; Russia; South Africa; Sweden; Ukraine

References

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.

Reference Type: DERIVED

PMID: 27622699 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Dataset Specification

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

View Document

Document Type: Informed Consent Form

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

106855

Identifier Type: -

Identifier Source: org_study_id