Status:
COMPLETED
Efficacy and Safety Study in Subjects With Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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), G...
Detailed Description
The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently rece...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00980200
Start Date
September 1 2009
End Date
January 1 2010
Last Update
January 30 2017
Active Locations (9)
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1
GSK Investigational Site
Cypress, California, United States, 90630
2
GSK Investigational Site
Huntington Beach, California, United States, 92647
3
GSK Investigational Site
Bethesda, Maryland, United States, 20814
4
GSK Investigational Site
Rolla, Missouri, United States, 65401