A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects with COPD
Trial overview
Number of participants with any non-serious adverse event (AE) and any serious adverse event (SAE) throughout the treatment period
Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of participants with any drug-related AE and any drug-related SAE throughout the treatment period
Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of participants with pneumonia during the treatment period
Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of participants for the indicated hematological parameters who experienced low, normal, and high levels at Baseline (BL) and Week 52/Withdrawal (WD)
Timeframe: Baseline (Week -2), and Week 52/Withdrawal (WD)
Number of participants for the indicated clinical chemistry and urinalysis parameters who experienced a low, normal, and high levels at Baseline (BL) and Week 52/Withdrawal (WD)
Timeframe: Baseline (Week -2), and Week 52/Withdrawal (WD
Number of participants for the indicated urinalysis parameters tested by dipstick at Baseline (BL) and Week 52/Withdrawal (WD)
Timeframe: Baseline (Week -2), Week 52/Withdrawal (WD)
Change from Baseline in 24-hour urinary cortisol excretion at Weeks 24 and 52/Withdrawal (WD)
Timeframe: Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
Change from Baseline in blood pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD
Change from Baseline in heart rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD
Number of participants with abnormal 12-lead electrocardiogram (ECG) findings
Timeframe: Baseline (Week -2), Week 12, Week 24, and Week 52
Participation criteria
- Out patient at least 40 years of age
- Both genders; females childbearing potencial must be willing to use birth control method
- Current diagnosis of sthma
- Respiratory disorders other than COPD
- Out patient at least 40 years of age
- Both genders; females childbearing potencial must be willing to use birth control method
- A diagnosis of COPD at Screening
- Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
- Post-bronchodilator FEV1/FVC ratio of less than 70%
- Post-bronchodilator FEV1 of less than 80%
- Current diagnosis of sthma
- Respiratory disorders other than COPD
- Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
- Concurrent other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' 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.