Last updated: 11/07/2018 01:43:12
Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study HZA106851: A Study of the Effects of Inhaled Fluticasone Furoate/GW642444 versus Placebo on the HPA Axis of Adolescent and Adult Asthmatics
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Ratio from Baseline of the serum cortisol weighted mean (0–24 hours) on Day -1/1 (Baseline) and Day 42
Timeframe: Day -1/1 (Baseline) and Day 42
Secondary outcomes:
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
Timeframe: Day -1/1 (Baseline) and Day 42
Ratio from Baseline of serum cortisol trough (0-24 hours) at Day -1/1 (Baseline) and Day 42
Timeframe: Day -1/1 (Baseline) and Day 42
Ratio from Baseline of 0-24 hour urinary free cortisol excretion on Day -1/1 (Baseline) and Day 42
Timeframe: Day -1/1 (Baseline) and Day 42
Plasma FF and VI Pharmacokinetic (PK) Concentration
Timeframe: Day 42
AUC(0-t) and AUC(0-24) for FF on Day 42
Timeframe: Day 42
Cmax for FF on Day 42
Timeframe: Day 42
tmax and tlast of FF at Day 42
Timeframe: Day 42
AUC(0-t) for VI on Day 42
Timeframe: Day 42
Cmax for VI on Day 42
Timeframe: Day 42
tmax and tlast of VI at Day 42
Timeframe: Day 42
Number of participants with any adverse event (AE) or any serious adverse event (SAE) during the Treatment Period
Timeframe: From the start of study medication until Day 42 (Visit 5)/Early Withdrawal
Change from Baseline in basophil, eosinophil, lymphocyte, monocyte, and segmented neutrophil values at Day 42/Early Withdrawal (EW)
Timeframe: Baseline and Day 42/Early Withdrawal (EW)
Change from Baseline in eosinophil, total neutrophil, platelet, and white blood cell (WBC) count values at Day 42/EW
Timeframe: Baseline and Day 42/EW
Change from Baseline in hemoglobin values at Day 42/EW
Timeframe: Baseline and Day 42/EW
Change from Baseline in hematocrit values at Day 42/EW
Timeframe: Baseline and Day 42/EW
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
Timeframe: Baseline and Day 42/EW
Change from Baseline in albumin and total protein values at Day 42/EW
Timeframe: Baseline and Day 42/EW
Change from Baseline in direct bilirubin, indirect bilirubin, total bilirubin, and creatinine values at Day 42/EW
Timeframe: Baseline and Day 42/EW
Change from Baseline in chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) values at Day 42/EW
Timeframe: Baseline and Day 42/EW
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Days 14, 28, 42, and maximum post-Baseline
Timeframe: Days 14, 28, 42, and EW
Change from Baseline in pulse rate at Days 14, 28, 42, and maximum post-Baseline
Timeframe: Days 14, 28, 42, and EW
Interventions:
Drug: Placebo Inhalation Powder
Drug: Fluticasone Furoate/GW642444 Inhalation Powder
Drug: Placebo Oral Capsule
Drug: Prednisolone Oral Capsule
Enrollment:
185
Observational study model:
Not applicable
Primary completion date:
2010-24-09
Time perspective:
Not applicable
Clinical publications:
Allen A, Schenkenberger I, Trivedi R, Cole J, Hicks W, Gul N, Jacques L. Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled study. Clin Respir J. 2013;7(4):397-406.
Allen A. The relationship between fluticasone furoate systemic exposure and cortisol suppression. Clin Pharmacokinet. 2013;52(10):885–96.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
March 2010 to September 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 65 years
Accepts healthy volunteers
No
- 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
- History of life threatening asthma
- Respiratory infection or oral candidiasis
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Cypress, California, United States, 90630
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-24-09
Actual study completion date
2010-24-09
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.
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