A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Moderate-Dose ICS Therapy.
A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent an
1 other identifier
interventional
627
16 countries
154
Brief Summary
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.
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 Dec 2007
154 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
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 27, 2007
CompletedFirst Posted
Study publicly available on registry
January 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2008
CompletedResults Posted
Study results publicly available
August 19, 2013
CompletedSeptember 15, 2017
August 1, 2017
9 months
December 27, 2007
June 12, 2013
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.
Baseline and Week 8
Secondary Outcomes (22)
Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period
From Baseline up to Week 8
Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period
From Baseline up to Week 8
Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period
From Baseline up to Week 8
Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period
From Baseline up to Week 8
Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period
From the first dose of the study medication up to Week 8/Early Withdrawal
- +17 more secondary outcomes
Study Arms (1)
GW685698X
EXPERIMENTALGW685698X
Interventions
Eligibility Criteria
You may qualify if:
- Subjects eligible for enrolment in the study must meet all of the following criteria:
- Type of Subject: Outpatient
- Age: 12 years of age or older at Visit 1. For sites in the following countries, subjects recruited will be ≥18 years of age: Bulgaria, Czech Republic, Germany, Greece, Lithuania, New Zealand, Russian Federation, Turkey and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only.
- \. Gender: Male or Eligible Female
- To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following:
- Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
- Implants of levonorgestrel
- Injectable progestogen
- Oral contraceptive (either combined estrogen/progestin or progestin only)
- Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
- Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days).
- Double barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm).
- NB: For German sites, female subjects must use a method of birth control other than the double barrier method.
- The contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds)
- Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required of all females. This test will be performed at the initial screening visit (Visit 1) and Visit 8. In addition, a urine pregnancy test will be performed on the evening of the double-blind treatment visit, prior to randomization (Visit 3) and at Visits 4 through 7.
- +10 more criteria
You may not qualify if:
- History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
- Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subject's asthma status or the subject's ability to participate in the study.
- Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1. A subject must not have had any hospitalization for asthma within 6 months prior to Visit 1.
- Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease including, but not limited to: cardiovascular disease, hepatic disease, renal disease, hematological disease, neurological disease, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. The list of additional excluded conditions/diseases includes, but is not limited to the following: congestive heart failure, clinically significant coronary artery disease, stroke within 3 months of Visit 1, poorly controlled peptic ulcer, immunologic compromise, tuberculosis (current or untreated), Addison's disease, uncontrolled thyroid disorder, known aortic aneurysm, clinically significant cardiac arrhythmia, uncontrolled hypertension, hematological, hepatic, or renal disease, current malignancy, cushings disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse.
- Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of oral candidiasis at Visit 1.
- Investigational Medications: A subject must not have participated in a study or used any investigational drug within 30 days prior to Visit 1.
- Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the novel dry powder inhaler or DISKUS/ACCUHALER (i.e., lactose or magnesium stearate).
- Milk Protein Allergy: History of severe milk protein allergy.
- Immunosuppressive Medications: A subject must not be using, or require use, of immunosuppressive medications during the study. NOTE: Immunotherapy for the treatment of allergies is allowed during the study provided that the treatment was initiated prior to Visit 1 and the subject is maintained on a stable regimen throughout the study period.
- Attendance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol or scheduled visits to the study center and non-compliant with study medication or procedures (e.g. completion of daily diary). Neurological or psychiatric disease or history of drug or alcohol abuse which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements excludes study participation.
- Tobacco Use : Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years). A subject may not have used tobacco products within the past one year (i.e., cigarettes, cigars, or pipe tobacco).
- Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
- Corticosteroid Use: Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1.
- Potent Cytochrome P450 3A4 (CYP3A4) inhibitors: Patients who are receiving potent CYP3A4 inhibitors within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).
- Clinical Laboratory Abnormalities: Clinically significant abnormal laboratory tests during Visit 1 which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality. When in doubt, GlaxoSmithKline, or designee, should be notified so that a joint decision can be made.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (154)
GSK Investigational Site
Phoenix, Arizona, 85028, United States
GSK Investigational Site
Fort Smith, Arkansas, 72903, United States
GSK Investigational Site
Little Rock, Arkansas, 72211-3733, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Granada Hills, California, 91344, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Los Angeles, California, 90095-1752, United States
GSK Investigational Site
Palmdale, California, 93551, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Roseville, California, 95678, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
West Covina, California, 91790, United States
GSK Investigational Site
Colorado Springs, Colorado, 80910, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Bridgeport, Connecticut, 06606, United States
GSK Investigational Site
Waterbury, Connecticut, 06708, United States
GSK Investigational Site
Boca Raton, Florida, 33487, United States
GSK Investigational Site
Cocoa, Florida, 32927, United States
GSK Investigational Site
Daytona Beach, Florida, 32114, United States
GSK Investigational Site
Largo, Florida, 33770, United States
GSK Investigational Site
Miami, Florida, 33157, United States
GSK Investigational Site
Miami, Florida, 33175, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Gainesville, Georgia, 30501, United States
GSK Investigational Site
Bloomingdale, Illinois, 60108, United States
GSK Investigational Site
Chicago, Illinois, 60617, United States
GSK Investigational Site
DeKalb, Illinois, 60115, United States
GSK Investigational Site
Gurnee, Illinois, 60031, United States
GSK Investigational Site
Evansville, Indiana, 47713, United States
GSK Investigational Site
Iowa City, Iowa, 52240, United States
GSK Investigational Site
Lenexa, Kansas, 66215, United States
GSK Investigational Site
Crescent Springs, Kentucky, 41017, United States
GSK Investigational Site
Metairie, Louisiana, 70002, United States
GSK Investigational Site
Bangor, Maine, 04401, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Detroit, Michigan, 48221, United States
GSK Investigational Site
Taylor, Michigan, 48180, United States
GSK Investigational Site
Ypsilanti, Michigan, 48197, United States
GSK Investigational Site
Rochester, Minnesota, 55905, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
St Louis, Missouri, 63143, United States
GSK Investigational Site
Warrensburg, Missouri, 64093, United States
GSK Investigational Site
Billings, Montana, 59101, United States
GSK Investigational Site
Butte, Montana, 59701, United States
GSK Investigational Site
Missoula, Montana, 59808, United States
GSK Investigational Site
Las Vegas, Nevada, 89107, United States
GSK Investigational Site
Clifton, New Jersey, 7011, United States
GSK Investigational Site
Hillsborough, New Jersey, 08844, United States
GSK Investigational Site
Little Silver, New Jersey, 07739, United States
GSK Investigational Site
Skillman, New Jersey, 08558, United States
GSK Investigational Site
East Syracuse, New York, 13057, United States
GSK Investigational Site
Ithaca, New York, 14850, United States
GSK Investigational Site
Rockville Centre, New York, 11570, United States
GSK Investigational Site
Greensboro, North Carolina, 27408, United States
GSK Investigational Site
Greenville, North Carolina, 27834, 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
Cleveland, Ohio, 44113, United States
GSK Investigational Site
Columbus, Ohio, 43235, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243, United States
GSK Investigational Site
Bluffton, South Carolina, 29910, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Knoxville, Tennessee, 37909, United States
GSK Investigational Site
Boerne, Texas, 78006, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Dickinson, Texas, 77539, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
San Antonio, Texas, 78205, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78233, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Manassas, Virginia, 20110, United States
GSK Investigational Site
Bellingham, Washington, 98225, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Spokane, Washington, 99207, United States
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Clayton, Victoria, 3168, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Pleven, 5800, Bulgaria
GSK Investigational Site
Rousse, 7000, Bulgaria
GSK Investigational Site
Sofia, 1431, Bulgaria
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
GSK Investigational Site
Ajax, Ontario, L1S 2J5, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Mississauga, Ontario, L5M 2V8, Canada
GSK Investigational Site
Ottawa, Ontario, K1Y 4G2, Canada
GSK Investigational Site
Toronto, Ontario, M3H 5S4, Canada
GSK Investigational Site
Québec, Quebec, G1V 4M6, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1, Canada
GSK Investigational Site
ValparaĂso, RegiĂ³n de ValparaĂso, 2341131, Chile
GSK Investigational Site
Puente Alto - Santiago, RegiĂ³n Metro de Santiago, 8207257, Chile
GSK Investigational Site
Santiago, RegiĂ³n Metro de Santiago, 7500551, Chile
GSK Investigational Site
Santiago, 8380453, Chile
GSK Investigational Site
Beroun, 266 01, Czechia
GSK Investigational Site
Brno, 639 00, Czechia
GSK Investigational Site
KutnĂ¡ Hora, 284 01, Czechia
GSK Investigational Site
TĂ¡bor, Czechia
GSK Investigational Site
Tallinn, 13619, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Grenoble, 38000, France
GSK Investigational Site
Marseille, 13009, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Gelnhausen, Hesse, 63571, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30167, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 13597, Germany
GSK Investigational Site
Guadalajara, Jalisco, 44100, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45040, Mexico
GSK Investigational Site
Distrito Federal, 06760, Mexico
GSK Investigational Site
MĂ©xico, 04530, Mexico
GSK Investigational Site
MĂ©xico, 11550, Mexico
GSK Investigational Site
Amsterdam, 1034 CS, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Hengelo, 7555 DL, Netherlands
GSK Investigational Site
Schiedam, 3116 BA, Netherlands
GSK Investigational Site
Utrecht, 3584 EA, Netherlands
GSK Investigational Site
Lima, Lima 1, Peru
GSK Investigational Site
Lima, Lima 27, Peru
GSK Investigational Site
Bialystok, 15-276, Poland
GSK Investigational Site
Warsaw, 02-097, Poland
GSK Investigational Site
Wroclaw, 50-434, Poland
GSK Investigational Site
Irkutsk, 664005, Russia
GSK Investigational Site
Kazan', 420015, Russia
GSK Investigational Site
Moscow, 115 280, Russia
GSK Investigational Site
Moscow, 123367, Russia
GSK Investigational Site
Tomsk, 634001, Russia
GSK Investigational Site
Bellville, 7530, South Africa
GSK Investigational Site
Durban, 4001, South Africa
GSK Investigational Site
eManzimtoti, 4126, South Africa
GSK Investigational Site
Mowbray, 7700, South Africa
GSK Investigational Site
Bangkok, 10330, Thailand
GSK Investigational Site
Bangkok, 10400, Thailand
Related Publications (2)
Busse WW, Bleecker ER, Bateman ED, Lotvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax. 2012 Jan;67(1):35-41. doi: 10.1136/thoraxjnl-2011-200308. Epub 2011 Aug 9.
PMID: 21828231BACKGROUNDO'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
PMID: 27881132DERIVED
Related Links
MeSH Terms
Conditions
Condition 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2007
First Posted
January 29, 2008
Study Start
December 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 20, 2008
Last Updated
September 15, 2017
Results First Posted
August 19, 2013
Record last verified: 2017-08
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.