Phase 3
Completed N=187
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01192191 ↗
Enrolled (actual)
187
Serious AEs
17.7%
Results posted
Aug 2013
Primary outcomePrimary: Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period — 36; 93; 10; 23 Participants
Summary
The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period |
36; 93; 10; 23 | — |
| PRIMARY Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period |
12; 30; 1; 2 | — |
| SECONDARY Number of Participants With Pneumonia During the Treatment Period |
6; 19; 4; 9 | — |
| SECONDARY Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) |
2; 0; 58; 127; 0; 0 | — |
| SECONDARY 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) |
0; 2; 56; 112; 4; 13 | — |
| SECONDARY Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) |
54; 112; 4; 6; 1; 5 | — |
| SECONDARY Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD) |
1.0627; 0.8160; 0.8862; 0.8593 | — |
| SECONDARY Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD |
4.3; 1.2; 2.5; 0.4; 2.7; 1.2 | — |
| SECONDARY 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 |
0.2; -0.3; -0.2; 0.3; -1.6; -0.1 | — |
| SECONDARY Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings |
0; 0; 19; 43; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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%
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01192191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.