Status:
COMPLETED
Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Mild Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of GSK256066 in the treatment of subjects with mild bronchial asthma, using a number of clinical and biological markers of efficacy.
Eligibility Criteria
Inclusion
- Inclusion criteria
- Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
- Pre-bronchodilator FEV1 \>75% of predicted at screening.
- Non-smoker
- Demonstration of a positive reaction to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair on skin prick testing at screening, or within 12 months of study start.
- Have Asthmatic response
- Able and willing to give written informed consent to take part in the study.
- Available to complete all study measurements.
- Exclusion criteria:
- History of cardiovascular disease
- Clinically significant abnormalities in safety laboratory analysis at screening including any subject who has greater than "trace urine protein levels" following urinalysis at screening.
- History of hayfever
- The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
- The subject has tested positive for HIV antibodies.
- The subject has positive drugs of abuse test.
- Subjects weighing less than 50kg are to be excluded from participating in the study.
- The subject has participated in a study with a new molecular entity during the previous 3 months.
- History of being unable to tolerate or complete methacholine, and/or allergen challenge tests.
- There is a risk of non-compliance with study medication or study procedures.
- History of blood donation (450 mL) within 2 months of starting the clinical study.
- The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00380354
Start Date
September 1 2006
End Date
June 1 2007
Last Update
June 4 2012
Active Locations (2)
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1
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
2
GSK Investigational Site
London, United Kingdom, SE1 9RT