Phase 3
Completed N=617
Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study
Source: ClinicalTrials.gov NCT01018186 ↗Enrolled (actual)
617
Serious AEs
2.2%
Results posted
Oct 2013
Primary outcomePrimary: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period — 139; 134; 73; 3 participants
Summary
The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period |
139; 134; 73; 3; 1; 7 | — |
| PRIMARY Number of Participants With Severe Asthma Exacerbations During the Treatment Period |
3; 6; 3 | — |
| PRIMARY Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal |
0.1; 0.2; -0.5; -0.2; -0.3; -0.4 | — |
| PRIMARY Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal |
-3.0; -2.6; -4.7; -1.0; -5.8; -5.7 | — |
| PRIMARY Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal |
-0.3; -0.3; -0.2; -0.3; -0.2; -0.1 | — |
| PRIMARY Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal |
-0.7; -0.4; 0.1; -0.1; 0.2; -0.1 | — |
| PRIMARY Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal |
-0.01; -0.06; -0.08; -0.01; 0.00; -0.06 | — |
| PRIMARY Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal |
-0.010; -0.057; -0.073; -0.039; -0.083; -0.083 | — |
| PRIMARY Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal |
-0.0073; -0.0013; -0.0025; -0.0017; -0.0005; -0.0028 | — |
| PRIMARY Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal |
-3.4; -1.8; -2.0; -2.1; -2.2; -2.4 | — |
| PRIMARY Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion |
6; 7; 2; 131; 128; 67 | — |
| PRIMARY Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline |
1.03; 0.93; 0.61 | <0.001 sig |
| PRIMARY Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline |
1.05; 0.91; 0.64 | <0.001 sig |
| PRIMARY Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline |
1.00; 1.04; 0.95 | 0.674 |
| PRIMARY Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline |
15; 14; 5; 13; 11; 3 | — |
| PRIMARY Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) |
10.2; 10.0; 11.3; -8.9; -9.0; -8.0 | — |
| PRIMARY Maximum Change From Baseline in Pulse Rate |
10.5; 10.0; 7.5 | — |
| PRIMARY Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 |
174; 175; 79; 5; 2; 1 | — |
| PRIMARY Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 |
71; 78; 32; 101; 92; 46 | — |
| PRIMARY Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 |
0.5; -0.2; 0.5; 0.2; -0.2; 0.5 | — |
| PRIMARY Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 |
167; 166; 75; 6; 5; 4 | — |
| PRIMARY Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 |
0.01; 0.00; -0.02; 0.01; 0.1; -0.02 | — |
| PRIMARY Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 |
0.02; 0.03; -0.02; 0.01; 0.03; -0.03 | — |
| PRIMARY Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 |
-0.008; -0.010; -0.004; -0.003; -0.001; -0.008 | — |
| PRIMARY Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) |
19.0; 16.4; 13.2; 12.8; 11.6; 11.4 | — |
| PRIMARY Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data |
79.0; 79.1; 79.8; 78.6; 78.7; 77.4 | — |
| PRIMARY Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data |
132.6; 132.1; 133.0; 131.2; 130.8; 129.2 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of asthma
- Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
- FEV1 greater than or equal to fifty percent of predicted
- Currently using moderate to high dose inhaled corticosteroid therapy
Exclusion Criteria
- History of life threatening asthma
- Respiratory infection or oral candidiasis
- Asthma exacerbation
- Uncontrolled disease or clinical abnormality
- Allergies
- Taking another investigational medication or prohibited medication
Data sourced from ClinicalTrials.gov (NCT01018186). 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.