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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01086410

Run by

GlaxoSmithKline

People needed

185

Starts

2010-03-01

Expected to finish

2010-09-01

Last updated by the study team

2017-01-18

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• GSK Investigational Site — Cypress, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Hamburg, Free and Hanseatic City of Hamburg, Germany
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Magdeburg, Saxony-Anhalt, Germany
• GSK Investigational Site — Großhansdorf, Schleswig-Holstein, Germany
• GSK Investigational Site — Berlin, State of Berlin, Germany
• GSK Investigational Site — Berlin, State of Berlin, Germany
• GSK Investigational Site — Bialystok, Poland
• GSK Investigational Site — Gdansk, Poland
• GSK Investigational Site — Gidle, Poland
• GSK Investigational Site — Krakow, Poland
• GSK Investigational Site — Lodz, Poland
• GSK Investigational Site — Olsztyn, Poland
• GSK Investigational Site — Warsaw, Poland

Full record on ClinicalTrials.gov

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