Phase 3
Completed N=243
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma
Source: ClinicalTrials.gov NCT01244984 ↗Enrolled (actual)
243
Serious AEs
4.9%
Results posted
Aug 2013
Primary outcomePrimary: Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) — 4; 7; 1; 52 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) |
4; 7; 1; 52; 77; 72 | — |
| SECONDARY Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
0.78; 0.71; 0.79; 0.76; 0.67; 0.79 | — |
| SECONDARY 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 |
0.338; 0.323; 0.323; 0.306; 0.245; 0.286 | — |
| SECONDARY Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD |
135.7; 141.1; 138.6; 138.2; 140.6; 139.1 | — |
| SECONDARY Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
0.4214; 0.4374; 0.4319; 0.4288; 0.4325; 0.4283 | — |
| SECONDARY Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
4.557; 4.714; 4.689; 4.656; 4.685; 4.696 | — |
| SECONDARY Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
44.3; 44.8; 44.7; 44.3; 44.1; 44.3 | — |
| SECONDARY 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 |
209.9; 222.7; 217.1; 217.9; 214.9; 220.3 | — |
| SECONDARY 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 |
3.220; 3.236; 3.401; 2.948; 3.230; 3.125 | — |
| SECONDARY 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 |
104.3; 104.2; 103.6; 105.9; 105.6; 105.6 | — |
| SECONDARY Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
6.33; 6.36; 6.46; 6.41; 6.36; 6.39 | — |
| SECONDARY Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD |
1.0177; 1.0177; 1.0173; 1.0171; 1.0167; 1.0163 | — |
| SECONDARY Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD |
51; 79; 81; 6; 5; 2 | — |
| SECONDARY Change From Baseline in the 24-hour Urinary Cortisol Excretion |
1.0218; 1.0602; 0.9698; 0.8956; 1.0802; 0.8190 | — |
| SECONDARY Change From Baseline in Blood Pressure |
-1.6; 1.2; 0.7; -0.7; -1.6; 0.1 | — |
| SECONDARY Change From Baseline in Heart Rate (HR) |
0.9; -0.6; 1.3; 0.1; 0.1; 1.1 | — |
| SECONDARY Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings |
19; 22; 11; 0; 0; 0 | — |
| SECONDARY Number of Participants With Severe Asthma Exacerbation During the Study Treatment |
3; 9; 16 | — |
| SECONDARY Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment |
18.29; 23.98; 12.38; 20.23; 26.29; 15.64 | — |
| SECONDARY Change From Baseline in Asthma Symptom Score During the Study Treatment |
-0.14; -0.14; -0.19 | — |
| SECONDARY Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment |
6.79; 6.51; 8.19 | — |
| SECONDARY Change From Baseline in the Percentage of Rescue-free 24-hour Periods |
97.94; 95.51; 92.79; 97.60; 95.94; 94.35 | — |
| SECONDARY Number of Rescue Medication Inhalations |
5.15; 7.32; 13.42; 5.12; 6.65; 12.56 | — |
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
Data sourced from ClinicalTrials.gov (NCT01244984). 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.