A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Non-steroidal 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 Administered Once Daily and Fluticasone Propionate Inhalation Powder 100mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy
1 other identifier
interventional
599
14 countries
149
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
149 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
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2008
CompletedResults Posted
Study results publicly available
August 19, 2013
CompletedApril 18, 2018
March 1, 2018
10 months
December 27, 2007
June 6, 2013
March 19, 2018
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 forcefully 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 through Week 8 clinic visits. Trough FEV1 is the FEV1 measured approximately 24 hours after the last administration of study drug. 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 of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
From the first dose of study medication up to Week 8/Early Withdrawal
- +17 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORGW685698X
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subjects eligible for enrollment 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 enrollment 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.
- +9 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 before Visit 1 and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects 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 heart 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 hypertension1, hematological, hepatic, or renal disease, current malignancy2, cushings disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse.
- systolic blood pressure ≥160, or diastolic blood pressure \>100
- history of malignancy is acceptable only if subject has been in remission for one year prior to Visit 1 (remission = no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to Visit 1)
- Patients with a history of tuberculosis who have received an approved prophylactic treatment regimen or an approved active treatment regimen and who have had no evidence of active disease for a minimum of 2 years may be enrolled \[American Thoracic Society, 2003; American Thoracic Society, 2005\]"
- 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).
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (149)
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, 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, 33126, United States
GSK Investigational Site
Miami, Florida, 33157, 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
Red Bank, New Jersey, 07701, 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, 29406, United States
GSK Investigational Site
Charleston, South Carolina, 29414, 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
Plovdiv, 4000, Bulgaria
GSK Investigational Site
Sofia, 1202, Bulgaria
GSK Investigational Site
Sofia, 1606, Bulgaria
GSK Investigational Site
Varna, 9010, 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
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 7H9, Canada
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Évreux, 27000, France
GSK Investigational Site
Montbrison, 42600, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Toulon, 83000, France
GSK Investigational Site
Toulouse, 31300, France
GSK Investigational Site
Vieux-Condé, 59690, France
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889, Germany
GSK Investigational Site
Potsdam, Brandenburg, 14469, Germany
GSK Investigational Site
Gelnhausen, Hesse, 63571, Germany
GSK Investigational Site
Marburg, Hesse, 35037, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10965, Germany
GSK Investigational Site
Guadalajara, Jalisco, 44100, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45040, Mexico
GSK Investigational Site
Monterrey N.L, Nuevo León, 64988, Mexico
GSK Investigational Site
Lima, Lima 1, Peru
GSK Investigational Site
Lima, Lima 27, Peru
GSK Investigational Site
Cavite, 4114, Philippines
GSK Investigational Site
Cebu City, 6000, Philippines
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Lodz, 90-153, Poland
GSK Investigational Site
Zawadzkie, 47-120, Poland
GSK Investigational Site
Barnaul, 656 045, Russia
GSK Investigational Site
Novokuznetsk, 654063, Russia
GSK Investigational Site
Samara, 443079, Russia
GSK Investigational Site
Smolensk, 214 019, Russia
GSK Investigational Site
Yaroslavl, 150003, Russia
GSK Investigational Site
Banská Bystrica, 975 17, Slovakia
GSK Investigational Site
Bratislava, 841 08, Slovakia
GSK Investigational Site
Martin, 036 59, Slovakia
GSK Investigational Site
Bucheon-si, 420-767, South Korea
GSK Investigational Site
Cheongju, Chungcheongbuk-do, 361-711, South Korea
GSK Investigational Site
Gwangju, 501-757, South Korea
GSK Investigational Site
Seoul, 110-744, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Suwon, Kyonggi-do, 443-721, South Korea
GSK Investigational Site
Boden, SE-961 64, Sweden
GSK Investigational Site
Luleå, SE-971 89, Sweden
Related Publications (4)
Bateman ED, Bleecker ER, Lotvall J, Woodcock A, Forth R, Medley H, Davis AM, Jacques L, Haumann B, Busse WW. Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial. Respir Med. 2012 May;106(5):642-50. doi: 10.1016/j.rmed.2012.01.004. Epub 2012 Feb 18.
PMID: 22342538BACKGROUNDPsaila B, Bussel JB, Linden MD, Babula B, Li Y, Barnard MR, Tate C, Mathur K, Frelinger AL, Michelson AD. In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation. Blood. 2012 Apr 26;119(17):4066-72. doi: 10.1182/blood-2011-11-393900. Epub 2012 Jan 31.
PMID: 22294727BACKGROUNDO'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: 27881132DERIVEDGross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.
PMID: 26704701DERIVED
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
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- 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
October 1, 2008
Study Completion
October 2, 2008
Last Updated
April 18, 2018
Results First Posted
August 19, 2013
Record last verified: 2018-03
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.