Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: GW685698X

Study type: Interventional

Funder types: Industry

Identifiers

NCT00766090

112202

Details and patient eligibility

About

The purpose of this study is to compare once and twice daily GW685698 in asthma

Enrollment: 190 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Clinical diagnosis of Asthma
• Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
• FEV1 between 40-85% predicted
• Currently on short acting beta2 agonist therapy

Key Exclusion Criteria:

• History of life threatening asthma
• Respiratory Infection or oropharyngeal candidiasis
• Asthma exacerbation
• Uncontrolled disease or clinical abnormality
• Allergies
• Taking another Investigational medications or other prohibited medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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190 participants in 1 patient group

GW685698X

Experimental group

Treatment:

Drug: GW685698X