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Protocol Summary for 112186

Protocol Summary
Protocol Id:	112186
Secondary Ids:	N/A
Title:	A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, 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
Phase:	phase 2
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CDER
IND/IDE Number:	IND 103220
IND/IDE Serial Number:
Has Expanded Access?:	no
Study Type:	Interventional
Oversight Authority:	Romania: National Medicines Agency United States: Food and Drug Administration Ukraine: State Pharmacological Center of Ministry of Health of Ukraine Japan: Pharmaceutical and Medical Device Agency Poland: Ministry of Health & Social Welfare Bulgaria: The Bulgarian Drug Agency
Collaborators:	N/A
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:
Record Verification Date:	April 2012
Status:	Completed
Why Study Stopped:
Study Start Date:	June 2010
Study Completion Date:	October 2011
Study Completion Date Type:	Actual
Primary Completion Date:	October 2011
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	yes
Masked Caregiver:	yes
Masked Investigator:	yes
Masked Assessor:	yes
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Mean change from baseline to the end of the treatment period in trough AM FEV1 8 weeks
Secondary Outcomes:	Mean change from baseline in daily PM PEF averaged over the treatment period 8 weeks Mean change from baseline in nighttime rescue SABA usage 8 weeks Mean change from baseline in day-time symptom scores 8 weeks Mean change from baseline in the percentage of rescue-free days during the treatment period 8 weeks Mean change from baseline in daily AM PEF averaged over the treatment period 8 weeks Mean change from baseline in nighttime symptom scores 8 weeks Mean change from baseline in the percentage of symptom-free days during the treatment period 8 weeks Mean change from baseline in the percentage of symptom-free nights during the treatment period 8 weeks Number of withdrawals due to lack of efficacy 8 weeks Mean change from baseline in day-time rescue SABA usage 8 weeks Mean change from baseline in the percentage of rescue-free nights during the treatment period 8 weeks
Conditions:	Asthma
Keywords:	Efficacy Asthma Safety Fluticasone Propionate FLAP Beta-agonists GSK2190915 Montelukast Placebo FLAIR
Eligibility Criteria:	Click to view inclusion/exclusion 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
Minimum Age:	12 Year
Maximum Age:
Enrollment:	700
Enrollment Type:	Actual
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Ukraine (click to view all sites in Ukraine) GSK Investigational Site Kyiv, 03680; COMPLETED; Contact: Yuriy I Feshchenko, Principal Investigator, . GSK Investigational Site Kyiv, ; COMPLETED; Contact: Volodymyr O Biloglazov, Principal Investigator, . GSK Investigational Site Kharkiv, 61002; RECRUITING; Contact: Larysa B Amer, Principal Investigator, . GSK Investigational Site Zaporizhia, 69035; COMPLETED; Contact: Oleg V Kraydashenko, Principal Investigator, . GSK Investigational Site Simferopol, 95043; COMPLETED; Contact: Valeriy M Zorin, Principal Investigator, . GSK Investigational Site Odesa, 65114; COMPLETED; Contact: Zinaida Y Telyatnikova, Principal Investigator, . GSK Investigational Site Kyiv, 04107; COMPLETED; Contact: Nina A Samuylenko, Principal Investigator, . GSK Investigational Site Kyiv, 02232; COMPLETED; Contact: Iurii Lymar, Principal Investigator, .

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Protocol Summary for 112186