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

GlaxoSmithKline (GSK) logo

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

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: 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: 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
Description:
Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral prednisolone 10mg capsule each day on the last 7 days of the study
Treatment:
Drug: Placebo Inhalation Powder
Drug: Prednisolone Oral Capsule

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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