Efficacy and Safety Study in Subjects With Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00980200

Run by

GlaxoSmithKline

People needed

75

Starts

2009-09-01

Expected to finish

2010-01-01

Last updated by the study team

2017-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Cypress, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Bethesda, Maryland, United States
• GSK Investigational Site — Rolla, Missouri, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Boerne, Texas, United States

Full record on ClinicalTrials.gov

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