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Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 21, 2006
Last updated: May 31, 2012
Last verified: February 2011
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.

Condition Intervention Phase
Asthma Mild Asthma Drug: GSK256066 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Asthmatic response [ Time Frame: after 7 days of treatment ]

Secondary Outcome Measures:
  • FEV1 Concentration of exhaled nitric oxide [ Time Frame: on day 8 of each treatment period ]
  • Incidence of treatment emergent adverse events [ Time Frame: throughout study ]

Enrollment: 11
Study Start Date: September 2006
Study Completion Date: June 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00380354

United Kingdom
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
GSK Investigational Site
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00380354     History of Changes
Other Study ID Numbers: IPA101985
Study First Received: September 21, 2006
Last Updated: May 31, 2012

Keywords provided by GlaxoSmithKline:
mild asthmatics
repeat dose
late asthmatic response

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017