Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis

NCT01086410 | Completed Phase 3 Results

• 1 other identifier: 106851
• Study Type: interventional
• Target: 185
• Locations: 3 countries
• Sites: 17

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

Conditions

Asthma

Keywords

HPA axis

Outcome Measures

Primary Outcomes (1)

• Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42

  Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 9, 12, 14, 16, 20, 22, and 24 hours (relative to the "0" time point). Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.

  Day -1/1 (Baseline) and Day 42

Secondary Outcomes (21)

• 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

  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

  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

  Day -1/1 (Baseline) and Day 42

• Plasma FF and VI Pharmacokinetic (PK) Concentration

  Day 42

• AUC(0-t) and AUC(0-24) for FF on Day 42

  Day 42

Study Arms (4)

FF/444 Dose B

ACTIVE COMPARATOR

Fluticasone furoate/GW642444 Dose B inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study

Drug: Fluticasone Furoate/GW642444 Inhalation Powder; Drug: Placebo Oral Capsule

FF/444 Dose A

ACTIVE COMPARATOR

Fluticasone furoate/GW642444 Dose A inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study

Drug: Fluticasone Furoate/GW642444 Inhalation Powder; Drug: Placebo Oral Capsule

Placebo

PLACEBO COMPARATOR

Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study

Drug: Placebo Inhalation Powder; Drug: Placebo Oral Capsule

Prednisolone

ACTIVE COMPARATOR

Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral prednisolone 10mg capsule each day on the last 7 days of the study

Drug: Placebo Inhalation Powder; Drug: Prednisolone Oral Capsule

Interventions

Placebo Inhalation Powder DRUG

Placebo Inhalation powder inhaled once daily for 6 weeks' treatment

Placebo; Prednisolone

Fluticasone Furoate/GW642444 Inhalation Powder DRUG

Dose B inhaled once daily for 6 weeks' treatment

FF/444 Dose B

Placebo Oral Capsule DRUG

One placebo capsule taken each day on the last 7 days of the study

FF/444 Dose A; FF/444 Dose B; Placebo

Prednisolone Oral Capsule DRUG

Prednisolone 10mg oral capsule taken each day on the last 7 days of the study

Prednisolone

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (17)

GSK Investigational Site

Cypress, California, 90630, United States

Location

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Hamburg, Hamburg, 20253, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10787, Germany

Location

GSK Investigational Site

Bialystok, 15-010, Poland

Location

GSK Investigational Site

Gdansk, 80-405, Poland

Location

GSK Investigational Site

Gidle, 97-540, Poland

Location

GSK Investigational Site

Krakow, 31-023, Poland

Location

GSK Investigational Site

Lodz, 93-513, Poland

Location

GSK Investigational Site

Olsztyn, 10-357, Poland

Location

GSK Investigational Site

Warsaw, 01-138, Poland

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate; Prednisolone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 18, 2017
• Results First Posted: August 8, 2013

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (6); US (4); PL (7)