Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
Overview[ - collapse ][ - ]
| Purpose | To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist. |
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| Condition | Asthma |
| Intervention | Drug: Fluticasone Propionate 100mcg BD Drug: GSK2190915 100mg Drug: GSK2190915 10mg Drug: GSK2190915 300mg Drug: GSK2190915 30mg Drug: Montelukast 10mg Drug: Placebo |
| Phase | Phase 2 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT01147744 |
| First Received | June 17, 2010 |
| Last Updated | March 13, 2014 |
| Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 17, 2010 |
|---|---|
| Last Updated Date | March 13, 2014 |
| Start Date | June 2010 |
| Estimated Primary Completion Date | October 2011 |
| Current Primary Outcome Measures | Mean change from baseline to the end of the treatment period in trough AM FEV1 [Time Frame: 8 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily |
|---|---|
| Official Title | A Randomised Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of GSK2190915 Tablets Administered Once Daily, Fluticasone Propionate Inhalation Powder 100mcg Twice Daily and Montelukast 10mg Once Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma While Treated With Short Acting Beta2-agonist. |
| Brief Summary | To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Asthma |
| Intervention | Drug: Fluticasone Propionate 100mcg BD Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS Drug: GSK2190915 100mg GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning Drug: GSK2190915 10mg GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning Drug: GSK2190915 300mg GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning Drug: GSK2190915 30mg GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning Drug: Montelukast 10mg Montelukast 10mg (1 x 10mg capsule) once daily in the evening Drug: Placebo Placebo tablets once daily in the morning, placebo capsules once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 700 |
| Estimated Completion Date | October 2011 |
| Estimated Primary Completion Date | October 2011 |
| Eligibility Criteria | Inclusion Criteria: - Type of Subject: Outpatient - Age: ≥12 years of age - Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control) - Asthma Diagnosis: As defined by NIH - Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio >0.70 - Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol - Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months - Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years - QTC: QTc(F)<450msec or QTc(F)<480 for subjects with Bundle Branch Block - Liver function: Normal liver function - Informed Consent Exclusion Criteria: - History of Life-threatening asthma: Within previous 5 years - Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months - Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate - Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks - OATP1B1 substrates: OATP1B1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks - Immunosuppressive medications: Either using or required during the study - Liver disease: Current or chronic history - Concurrent disease/abnormalities: Clinically significant uncontrolled disease - Investigational medications: Participation in a study or used investigational drug within 30 days - Drug allergy: β-agonists, corticosteroids, constituents of inhalers - Milk Protein Allergy: History of severe milk protein allergy - Compliance: Factors likely to impair compliance either with regards to study medication, procedures or attendance - Unable or unwilling to follow instructions: Procedures, dosing directions, e-diaries or pMDIs - History of alcohol or drug abuse: Likely to interfere with the study - Affiliation with Investigator's Site: Relative or employee |
| Gender | Female |
| Ages | 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Bulgaria, Japan, Poland, Romania, Ukraine |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01147744 |
|---|---|
| Other Study ID Numbers | 112186 |
| Has Data Monitoring Committee | No |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
| Verification Date | January 2014 |
Locations[ + expand ][ + ]
| GSK Investigational Site | Birmingham, Alabama, United States, 35209 |
|---|---|
| GSK Investigational Site | Huntington Beach, California, United States, 92647 |
| GSK Investigational Site | Newport Beach, California, United States, 92663 |
| GSK Investigational Site | San Diego, California, United States, 92123 |
| GSK Investigational Site | Tallahassee, Florida, United States, 32308 |
| GSK Investigational Site | Owensboro, Kentucky, United States, 42301 |
| GSK Investigational Site | Metairie, Louisiana, United States, 70006 |
| GSK Investigational Site | Bangor, Maine, United States, 04401 |
| GSK Investigational Site | Ypsilanti, Michigan, United States, 48197 |
| GSK Investigational Site | Minneapolis, Minnesota, United States, 55402 |
| GSK Investigational Site | Columbia, Missouri, United States, 65203 |
| GSK Investigational Site | Rolla, Missouri, United States, 65401 |
| GSK Investigational Site | St. Louis, Missouri, United States, 63141 |
| GSK Investigational Site | Ocean, New Jersey, United States, 07712 |
| GSK Investigational Site | Raleigh, North Carolina, United States, 27607 |
| GSK Investigational Site | Canton, Ohio, United States, 44718 |
| GSK Investigational Site | Oklahoma City, Oklahoma, United States, 73103 |
| GSK Investigational Site | Medford, Oregon, United States, 97504 |
| GSK Investigational Site | Orangeburg, South Carolina, United States, 29118 |
| GSK Investigational Site | San Antonio, Texas, United States, 78229 |
| GSK Investigational Site | Waco, Texas, United States, 76712 |
| GSK Investigational Site | Bellingham, Washington, United States, 98225 |
| GSK Investigational Site | Pleven, Bulgaria, 5800 |
| GSK Investigational Site | Plovdiv, Bulgaria, 4003 |
| GSK Investigational Site | Ruse, Bulgaria, 7000 |
| GSK Investigational Site | Sofia, Bulgaria, 1431 |
| GSK Investigational Site | Sofia, Bulgaria, 1202 |
| GSK Investigational Site | Sofia, Bulgaria, 1407 |
| GSK Investigational Site | Sofia, Bulgaria, 1000 |
| GSK Investigational Site | Stara Zagora, Bulgaria, 6000 |
| GSK Investigational Site | Varna, Bulgaria, 9010 |
| GSK Investigational Site | Chiba, Japan, 292-0805 |
| GSK Investigational Site | Fukuoka, Japan, 819-0006 |
| GSK Investigational Site | Fukuoka, Japan, 819-1102 |
| GSK Investigational Site | Hokkaido, Japan, 062-0034 |
| GSK Investigational Site | Hokkaido, Japan, 064-0801 |
| GSK Investigational Site | Ibaraki, Japan, 319-1113 |
| GSK Investigational Site | Kanagawa, Japan, 210-0852 |
| GSK Investigational Site | Osaka, Japan, 530-0001 |
| GSK Investigational Site | Osaka, Japan, 565-0853 |
| GSK Investigational Site | Saitama, Japan, 343-0851 |
| GSK Investigational Site | Tokyo, Japan, 158-0097 |
| GSK Investigational Site | Tokyo, Japan, 103-0027 |
| GSK Investigational Site | Tokyo, Japan, 102-0083 |
| GSK Investigational Site | Tokyo, Japan, 154-0024 |
| GSK Investigational Site | Tokyo, Japan, 153-0051 |
| GSK Investigational Site | Tokyo, Japan, 190-0013 |
| GSK Investigational Site | Tokyo, Japan, 171-0014 |
| GSK Investigational Site | Tokyo, Japan, 130-8587 |
| GSK Investigational Site | Tokyo, Japan, 103-0028 |
| GSK Investigational Site | Bialystok, Poland, 15-084 |
| GSK Investigational Site | Katowice, Poland, 40-018 |
| GSK Investigational Site | Krakow, Poland, 31-024 |
| GSK Investigational Site | Libiaz, Poland, 32-590 |
| GSK Investigational Site | Lodz, Poland, 93-329 |
| GSK Investigational Site | Poznan, Poland, 60-693 |
| GSK Investigational Site | Tarnow, Poland, 33-100 |
| GSK Investigational Site | Brasov, Romania, 500112 |
| GSK Investigational Site | Bucharest, Romania, 050159 |
| GSK Investigational Site | Bucharest, Romania, 022102 |
| GSK Investigational Site | Bucharest, Romania, 020125 |
| GSK Investigational Site | Cluj-Napoca, Romania, 400217 |
| GSK Investigational Site | Cluj-Napoca, Romania, 400371 |
| GSK Investigational Site | Deva, Romania, 330084 |
| GSK Investigational Site | Timisoara, Romania, 300310 |
| GSK Investigational Site | Dnipropetrovsk, Ukraine, 49051 |
| GSK Investigational Site | Dnipropetrovsk, Ukraine, 49027 |
| GSK Investigational Site | Dnipropetrovsk, Ukraine, 49006 |
| GSK Investigational Site | Donetsk, Ukraine, 83099 |
| GSK Investigational Site | Ivano-Frankivsk, Ukraine, 76018 |
| GSK Investigational Site | Kharkiv, Ukraine, 61124 |
| GSK Investigational Site | Kharkiv, Ukraine, 61002 |
| GSK Investigational Site | Kharkiv, Ukraine, 61037 |
| GSK Investigational Site | Kiev, Ukraine, 03680 |
| GSK Investigational Site | Kyiv, Ukraine, 04201 |
| GSK Investigational Site | Kyiv, Ukraine, 03680 |
| GSK Investigational Site | Kyiv, Ukraine, 02232 |
| GSK Investigational Site | Kyiv, Ukraine |
| GSK Investigational Site | Kyiv, Ukraine, 04107 |
| GSK Investigational Site | Kyiv, Ukraine, 03115 |
| GSK Investigational Site | Odesa, Ukraine, 65114 |
| GSK Investigational Site | Simferopol, Ukraine, 95043 |
| GSK Investigational Site | Yalta, Ukraine, 98603 |
| GSK Investigational Site | Zaporizhia, Ukraine, 69035 |