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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Prednisolone Oral Capsule

Drug: Placebo Inhalation Powder

Drug: Fluticasone Furoate/GW642444 Inhalation Powder

Drug: Placebo Oral Capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01086410

106851

Details and patient eligibility

About

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

Enrollment

185 patients

Sex

All

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

185 participants in 4 patient groups, including a placebo group

FF/444 Dose B

Active Comparator group

Description:

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

Treatment:

Drug: Fluticasone Furoate/GW642444 Inhalation Powder

Drug: Placebo Oral Capsule

FF/444 Dose A

Active Comparator group

Description:

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

Treatment:

Drug: Fluticasone Furoate/GW642444 Inhalation Powder

Drug: Placebo Oral Capsule

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Inhalation Powder

Drug: Placebo Oral Capsule

Prednisolone

Active Comparator group