Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380354
• Other study ID #: IPA101985
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2006
• Last updated: May 31, 2012
• Start date: September 2006
• Est. completion date: June 2007

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Mild Asthma

Intervention

Drug:
• GSK256066

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthmatic response		after 7 days of treatment
Secondary	FEV1 Concentration of exhaled nitric oxide		on day 8 of each treatment period
Secondary	Incidence of treatment emergent adverse events		throughout study