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Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

Primary Purpose

Asthma, Mild Asthma

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

GSK256066

About this trial

This is an interventional treatment trial for Asthma focused on measuring allergen, methacholine, GSK256066, mild asthmatics, repeat dose, challenge, late asthmatic response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Outcomes

Primary Outcome Measures

Asthmatic response

Secondary Outcome Measures

FEV1 Concentration of exhaled nitric oxide

Incidence of treatment emergent adverse events

Full Information

NCT ID

NCT00380354

First Posted

September 21, 2006

Last Updated

May 31, 2012

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00380354

Brief Title

Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Mild Asthma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

GSK256066

Primary Outcome Measure Information:

Title

Asthmatic response

Time Frame

after 7 days of treatment

Secondary Outcome Measure Information:

Title

FEV1 Concentration of exhaled nitric oxide

Time Frame

on day 8 of each treatment period

Title

Incidence of treatment emergent adverse events

Time Frame

throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Lancashire

ZIP/Postal Code

M23 9LT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

20193079

Citation

Singh D, Petavy F, Macdonald AJ, Lazaar AL, O'Connor BJ. The inhaled phosphodiesterase 4 inhibitor GSK256066 reduces allergen challenge responses in asthma. Respir Res. 2010 Mar 1;11(1):26. doi: 10.1186/1465-9921-11-26.

Results Reference

derived

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Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

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