Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Fluticasone propionate; Drug: Fluticasone Furoate/GW642444

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018186

106839

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444

Enrollment: 503 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of asthma
• Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
• FEV1 greater than or equal to fifty percent of predicted
• Currently using moderate to high dose inhaled corticosteroid therapy

Exclusion criteria

• History of life threatening asthma
• Respiratory infection or oral candidiasis
• Asthma exacerbation
• Uncontrolled disease or clinical abnormality
• Allergies
• Taking another investigational medication or prohibited medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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503 participants in 2 patient groups

Fluticasone furoate/GW642444

Experimental group

Treatment:

Drug: Fluticasone Furoate/GW642444

Fluticasone propionate

Active Comparator group

Treatment:

Drug: Fluticasone propionate