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
Overview
- Phase
- Phase 3
- Intervention
- Fluticasone Furoate/GW642444 Inhalation Powder
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 243
- Locations
- 1
- Primary Endpoint
- Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Fluticasone Furoate/GW642444
Combination inhaled corticosteroid and long-acting beta2-agonist
Intervention: Fluticasone Furoate/GW642444 Inhalation Powder
Fluticasone Furoate
Inhaled corticosteroid
Intervention: Fluticasone Furoate Inhalation Powder
Outcomes
Primary Outcomes
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
Time Frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAE.
Secondary Outcomes
- Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD(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(Baseline (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(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(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(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(Baseline (Week -2), Week 12, Week 24, and Week 52/WD)
- Number of Participants With Severe Asthma Exacerbation During the Study Treatment(Baseline up to Week 52)
- Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment(Baseline up to Week 52)
- Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD(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(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(Baseline (Week -2), Week 12, Week 24, and Week 52/WD)
- Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD(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(Baseline (Week -2), Week 12, Week 24, and Week 52/WD)
- Change From Baseline in the 24-hour Urinary Cortisol Excretion(Baseline (Week 0), Week 24, and Week 52/WD)
- Change From Baseline in Blood Pressure(Baseline (Week 0), Week 12, Week 24, and Week 52/WD)
- Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings(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(Baseline (Week -2), Week 12, Week 24, and Week 52/WD)
- Change From Baseline in Heart Rate (HR)(Baseline (Week 0), Week 12, Week 24, and Week 52/WD)
- Change From Baseline in Asthma Symptom Score During the Study Treatment(Baseline up to Week 52)
- Number of Rescue Medication Inhalations(Baseline up to Week 52)
- Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment(Baseline up to Week 52)
- Change From Baseline in the Percentage of Rescue-free 24-hour Periods(Baseline up to Week 52)