Efficacy and Safety Study in Subjects With Asthma

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Outpatient

• ≥18 years of age at Visit 1

• Male or Eligible Female

• Diagnosis of asthma at least 12 weeks prior to Visit 1

• Disease reversibility

• Current anti-asthma therapy

• Appropriately signed and dated informed consent has been obtained

• Able to comply with all the study requirements

Exclusion Criteria:

• History of Life-Threatening Asthma

• No use of systemic corticosteroids for any indication within 8 weeks prior to Visit

• No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation

• Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate

• History of severe milk protein allergy

• Non-compliance with study medication and other study-related requirements

• No use of inhaled tobacco products within the past three months or historical use of 10 pack years or more

• Administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol