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

NCT ID: NCT01086410

Last Updated: 2017-01-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FF/444 Dose B

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

Group Type ACTIVE_COMPARATOR

Fluticasone Furoate/GW642444 Inhalation Powder

Intervention Type DRUG

Dose B inhaled once daily for 6 weeks' treatment

Placebo Oral Capsule

Intervention Type DRUG

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

FF/444 Dose A

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

Group Type ACTIVE_COMPARATOR

Fluticasone Furoate/GW642444 Inhalation Powder

Intervention Type DRUG

Dose A inhaled once daily for 6 weeks' treatment

Placebo Oral Capsule

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Inhalation Powder

Intervention Type DRUG

Placebo Inhalation powder inhaled once daily for 6 weeks' treatment

Placebo Oral Capsule

Intervention Type DRUG

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

Prednisolone

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

Group Type ACTIVE_COMPARATOR

Placebo Inhalation Powder

Intervention Type DRUG

Placebo Inhalation powder inhaled once daily for 6 weeks' treatment

Prednisolone Oral Capsule

Intervention Type DRUG

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

Interventions

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Placebo Inhalation Powder

Placebo Inhalation powder inhaled once daily for 6 weeks' treatment

Intervention Type DRUG

Fluticasone Furoate/GW642444 Inhalation Powder

Dose B inhaled once daily for 6 weeks' treatment

Intervention Type DRUG

Fluticasone Furoate/GW642444 Inhalation Powder

Dose A inhaled once daily for 6 weeks' treatment

Intervention Type DRUG

Placebo Oral Capsule

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

Intervention Type DRUG

Prednisolone Oral Capsule

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Cypress, California, United States

Site Status

GSK Investigational Site

Huntington Beach, California, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Bialystok, , Poland

Site Status

GSK Investigational Site

Gdansk, , Poland

Site Status

GSK Investigational Site

Gidle, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Lodz, , Poland

Site Status

GSK Investigational Site

Olsztyn, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

Countries

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United States Germany Poland

Study Documents

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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

Other Identifiers

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106851

Identifier Type: -

Identifier Source: org_study_id

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