A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Fluticasone Furoate/GW642444 Inhalation Powder (Drug); Fluticasone Furoate Inhalation Powder (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
The primary purpose of the study is to assess the safety and tolerability of 52-week
teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation
powder once-daily in Japanese adult subjects with asthma.
Clinical Details
Official title: A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and FF Inhalation Powder in Japanese Subjects With Asthma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
Secondary outcome: Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WDLaboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD Change From Baseline in the 24-hour Urinary Cortisol Excretion Change From Baseline in Blood Pressure Change From Baseline in Heart Rate (HR) Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings Number of Participants With Severe Asthma Exacerbation During the Study Treatment Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment Change From Baseline in Asthma Symptom Score During the Study Treatment Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment Change From Baseline in the Percentage of Rescue-free 24-hour Periods Number of Rescue Medication Inhalations
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Out patient at least 18 years of age
- Both genderds; females of childbearing potential must be willing to use birth control
method
- A diagnosis of asthma at least 6 months prior to Screening
- A best FEV1 of at least 50% of the predicted nomal value at Screening
- Subjects have been receiving maintanance therapy for asthma, for at least 4 weeks
prior to Screening
Exclusion Criteria:
- History of life-threating asthma
- Respiratory infection or oral candidiasis
- Asthma exacerbation within 12 weeks
- Concurrent respiratory disease or other disease that would confound study
participation or affect subject safety
- Allergies to study drugs, study drugs7 excipients, medications related to study drugs
- Taking another investigational medication or medication prohibited for use during
this study
Locations and Contacts
GSK Investigational Site, Chiba 277-0863, Japan
GSK Investigational Site, Fukuoka 802-0083, Japan
GSK Investigational Site, Fukuoka 816-0813, Japan
GSK Investigational Site, Gifu 501-6062, Japan
GSK Investigational Site, Gunma 373-0021, Japan
GSK Investigational Site, Hiroshima 730-0844, Japan
GSK Investigational Site, Hiroshima 732-0062, Japan
GSK Investigational Site, Hiroshima 739-0402, Japan
GSK Investigational Site, Hyogo 665-0827, Japan
GSK Investigational Site, Hyogo 670-0046, Japan
GSK Investigational Site, Hyogo 672-8064, Japan
GSK Investigational Site, Ibaraki 302-0022, Japan
GSK Investigational Site, Kanagawa 231-8682, Japan
GSK Investigational Site, Kanagawa 253-0041, Japan
GSK Investigational Site, Kyoto 601-1495, Japan
GSK Investigational Site, Kyoto 615-8087, Japan
GSK Investigational Site, Miyagi 983-0824, Japan
GSK Investigational Site, Miyagi 983-8520, Japan
GSK Investigational Site, Nagano 390-0303, Japan
GSK Investigational Site, Nagano 390-8510, Japan
GSK Investigational Site, Okayama 700-0862, Japan
GSK Investigational Site, Okayama 701-0304, Japan
GSK Investigational Site, Okayama 714-0081, Japan
GSK Investigational Site, Osaka 545-8586, Japan
GSK Investigational Site, Osaka 569-1192, Japan
GSK Investigational Site, Osaka 589-0022, Japan
GSK Investigational Site, Tokyo 105-0004, Japan
GSK Investigational Site, Tokyo 134-0083, Japan
GSK Investigational Site, Tokyo 185-0014, Japan
GSK Investigational Site, Toyama 937-0066, Japan
Additional Information
Starting date: July 2010
Last updated: August 15, 2013
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