GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Trial overview
Number of participants with any adverse events (AEs) and serious AEs (SAEs)
Timeframe: Up to Week 56
Number of participants with abnormal (outliers from the normal range) hematology parameters
Timeframe: Up to Week 56
Number of participants with abnormal (outliers from the normal range) clinical chemistry parameters
Timeframe: Up to Week 56
Number of participants with abnormal (shift from Baseline) urinalysis parameters
Timeframe: Up to Week 56
Mean change from Baseline in level of plasma cortisol 1
Timeframe: Baseline and Week 24 and 52
Mean level of plasma cortisol 2
Timeframe: Up to Week 56
Mean change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timeframe: Baseline and up to Week 56
Mean change from Baseline in pulse rate
Timeframe: Baseline and up to Week 56
Number of participants with abnormal oropharyngeal examination findings
Timeframe: Up to Week 56
Number of participants with abnormal (clinically significant) electrocardiogram (ECG) findings
Timeframe: Up to Week 56
Mean change from Baseline in bone mineral density (BMD)
Timeframe: Baseline and up to Week 56
Mean change from Baseline in weight
Timeframe: Baseline and up to Week 56
Number of participants with abnormal (clinically significant) ophthalmological examinations findings
Timeframe: Up to Week 56
Mean change from Baseline in peak expiratory flow (PEF)
Timeframe: Baseline and up to Week 52
Mean change from Baseline in forced vital capacity (FVC)
Timeframe: Baseline and up to Week 52
Mean change from Baseline in maximal expiratory flow rate at 25% (V25) and 50% (V50) of vital capacity
Timeframe: Baseline and up to Week 52
Mean change from Baseline in percent of days without use of rescue medication
Timeframe: Baseline and up to Week 52
Change from Baseline in symptom score with respect to breathlessness, cough, sputum and nighttime awakenings
Timeframe: Baseline and up to Week 52
Mean frequency of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations
Timeframe: Up to Week 56
Mean observed maximum plasma concentration (Cmax) of fluticasone propionate (FP)
Timeframe: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours
Mean Cmax of Salmeterol
Timeframe: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours
Median time of observed maximum plasma concentration (tmax) of FP
Timeframe: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours
Median tmax of Salmeterol
Timeframe: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours
Mean area under the plasma concentration-time curve over a dosing interval [AUC(0-tau)] of FP
Timeframe: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours
Mean area under the plasma concentration-time curve from zero up to the last quantifiable plasma concentration [AUC (0-t)] of Salmeterol
Timeframe: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours
Participation criteria
- Diagnosis of COPD.
- Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
- Other inclusion and exclusion criteria will be evaluated at the first study visit.
- Diagnosis of COPD.
- Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
- Other inclusion and exclusion criteria will be evaluated at the first study visit.
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.