A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects with Asthma
Trial overview
Number of participants with any non-serious adverse event (AE) and any serious adverse event (SAE)
Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Laboratory parameters of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Change from Baseline in the 24-hour urinary cortisol excretion
Timeframe: Baseline (Week 0), Week 24, and Week 52/WD
Change from Baseline in blood pressure
Timeframe: Baseline (Week 0), Week 12, Week 24, and Week 52/WD
Change from Baseline in heart rate (HR)
Timeframe: Baseline (Week 0), Week 12, Week 24, and Week 52/WD
Number of participants with abnormal 12-lead electrocardiogram (ECG) findings
Timeframe: Week 12, Week 24, and Week 52/WD
Number of participants with severe asthma exacerbation during the study treatment
Timeframe: 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
Timeframe: Baseline up to Week 52
Change from Baseline in asthma symptom score during the study treatment
Timeframe: Baseline up to Week 52
Change from Baseline in the percentage of symptom-free 24-hour periods during the study treatment
Timeframe: Baseline up to Week 52
Change from Baseline in the percentage of rescue-free 24-hour periods
Timeframe: Baseline up to Week 52
Number of Rescue Medication Inhalations
Timeframe: Baseline up to Week 52
Participation criteria
- Out patient at least 18 years of age
- Both genderds; females of childbearing potential must be willing to use birth control method
- History of life-threating asthma
- Respiratory infection or oral candidiasis
- 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
- 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
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.