Clinical trial NCT01086410: Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: HPA axis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 185
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: 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:
measure: 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
measure: 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
measure: 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
measure: Plasma FF and VI Pharmacokinetic (PK) Concentration
timeFrame: Day 42
measure: AUC(0-t) and AUC(0-24) for FF on Day 42
timeFrame: Day 42
measure: Cmax for FF on Day 42
timeFrame: Day 42
measure: Tmax and Tlast of FF at Day 42
timeFrame: Day 42
measure: AUC(0-t) for VI on Day 42
timeFrame: Day 42
measure: Cmax for VI on Day 42
timeFrame: Day 42
measure: Tmax and Tlast of VI at Day 42
timeFrame: Day 42
measure: 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
measure: 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)
measure: 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
measure: Change From Baseline in Hemoglobin Values at Day 42/EW
timeFrame: Baseline and Day 42/EW
measure: Change From Baseline in Hematocrit Values at Day 42/EW
timeFrame: Baseline and Day 42/EW
measure: 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
measure: Change From Baseline in Albumin and Total Protein Values at Day 42/EW
timeFrame: Baseline and Day 42/EW
measure: Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW
timeFrame: Baseline and Day 42/EW
measure: 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
measure: 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
measure: Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline
timeFrame: Days 14, 28, 42, and EW
Other outcomes:
Locations:
city: Cypress
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Grosshansdorf
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gidle
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: