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

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GSK study ID
106851
See study documents
Clinicaltrials.gov ID
NCT01086410
See results summary
EudraCT ID
2009-017669-44
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2010-24-09
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Magdeburg, Sachsen-Anhalt, Germany, 39112
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Warszawa, Poland, 01-138
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lodz, Poland, 93-513
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10117
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Olsztyn, Poland, 10-357
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 17 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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.

    Additional information about the trial

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