Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

Study Overview
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Brief Summary
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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.

Official Title
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A Two-centre, Randomised, Double-blind, Placebo-controlled, 2-period Cross-over Study to Evaluate the Effect of Treatment With Repeat Doses of Inhaled GSK256066 on the Allergen-induced Late Asthmatic Response in Subjects With Mild Asthma

Conditions
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Asthma, Mild Asthma

Intervention / Treatment
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* Drug: GSK256066


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK256066|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthmatic response |  | after 7 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 Concentration of exhaled nitric oxide |  | on day 8 of each treatment period | 
| Incidence of treatment emergent adverse events |  | throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergen, methacholine, GSK256066, mild asthmatics, repeat dose, challenge, late asthmatic response