Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00380354

Enrollment

Registered

2006-09-25

Start date

2006-09-30

Completion date

2007-06-30

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Mild Asthma

Keywords

allergen, methacholine, GSK256066, mild asthmatics, repeat dose, challenge, late asthmatic response

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.

Interventions

DRUGGSK256066

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Asthmatic response	after 7 days of treatment

Secondary

Measure	Time frame
FEV1 Concentration of exhaled nitric oxide	on day 8 of each treatment period
Incidence of treatment emergent adverse events	throughout study

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026