Phase 3
Completed N=185
Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis
Source: ClinicalTrials.gov NCT01086410 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42 — 0.99; 0.99; 0.96; 0.32 ratio from Baseline
Summary
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42 |
0.99; 0.99; 0.96; 0.32 | — |
| SECONDARY Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42 |
0.99; 0.99; 0.97; 0.32 | — |
| SECONDARY Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42 |
1.04; 0.84; 0.73; 0.28 | — |
| SECONDARY Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42 |
0.87; 1.03; 0.92; 0.40 | — |
| SECONDARY Plasma FF and VI Pharmacokinetic (PK) Concentration |
3.57; 10.02; 16.65; 25.55; 16.35; 28.84 | — |
| SECONDARY AUC(0-t) and AUC(0-24) for FF on Day 42 |
58.842; 221.694; NA; 324.015 | — |
| SECONDARY Cmax for FF on Day 42 |
19.388; 33.017 | — |
| SECONDARY Tmax and Tlast of FF at Day 42 |
0.500; 0.500; 9.000; 20.042 | — |
| SECONDARY AUC(0-t) for VI on Day 42 |
41.177; 66.937 | — |
| SECONDARY Cmax for VI on Day 42 |
101.227; 118.531 | — |
| SECONDARY Tmax and Tlast of VI at Day 42 |
0.083; 0.083; 0.500; 0.950 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period |
16; 23; 21; 5; 0; 0 | — |
| SECONDARY Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) |
0.05; 0.04; -0.05; -0.08; -0.10; 0.10 | — |
| SECONDARY Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW |
0.066; 0.044; -0.022; -0.036; 0.015; -0.060 | — |
| SECONDARY Change From Baseline in Hemoglobin Values at Day 42/EW |
-5.8; -6.2; -5.7; -3.5; -10.5; -3.0 | — |
| SECONDARY Change From Baseline in Hematocrit Values at Day 42/EW |
-0.0123; -0.0120; -0.0114; -0.0072; -0.0175; -0.0050 | — |
| SECONDARY Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW |
-1.3; -2.0; -2.2; 0.8; -5.0; 0.5 | — |
| SECONDARY Change From Baseline in Albumin and Total Protein Values at Day 42/EW |
-2.7; -1.5; -1.3; -0.3; -1.5; 0.5 | — |
| SECONDARY Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW |
-0.6; -0.6; -0.5; 0.3; -1.0; 0.0 | — |
| SECONDARY Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW |
1.2; 0.9; 0.7; -1.0; 2.0; -0.5 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline |
-0.5; -1.9; -1.3; -1.0; -0.9; -0.7 | — |
| SECONDARY Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline |
1.5; 1.7; 0.0; -1.8; 2.9; -0.9 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatient with ability to comply with study requirements and complete two 24-hour clinic visits
- Clinical diagnosis of asthma for greater than/equal to 12 weeks
- Reversibility FEV1 of at least twelve percent and two hundred milliliters
- FEV1 greater than or equal to fifty percent of predicted
Exclusion Criteria
- History of life threatening asthma
- Respiratory infection or oral candidiasis
- Asthma exacerbation
- Uncontrolled disease or clinical abnormality
- Allergies to study drugs, study drugs' excipients, medications related to study drugs
- Taking another investigational medication or prohibited medication
Data sourced from ClinicalTrials.gov (NCT01086410). 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.