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

NCT01086410 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2017-01-18

Study results available
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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

Interventions

DRUG

Placebo Inhalation Powder

Placebo Inhalation powder inhaled once daily for 6 weeks' treatment

DRUG

Fluticasone Furoate/GW642444 Inhalation Powder

Dose B inhaled once daily for 6 weeks' treatment

DRUG

Fluticasone Furoate/GW642444 Inhalation Powder

Dose A inhaled once daily for 6 weeks' treatment

DRUG

Placebo Oral Capsule

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

DRUG

Prednisolone Oral Capsule

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States
  • Germany
  • Poland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01086410 on ClinicalTrials.gov