Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Asthma

Mild Asthma

Treatments

Drug: GSK256066

Study type

Interventional

Funder types

Industry

Identifiers

NCT00380354

IPA101985

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.