Trial record 3 of 2436 for:    "Asthma"

Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00380354
First received: September 21, 2006
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Intervention Details:
    Drug: GSK256066
    Other Name: GSK256066
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380354

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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00380354     History of Changes
Other Study ID Numbers: IPA101985
Study First Received: September 21, 2006
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
allergen
methacholine
GSK256066
mild asthmatics
repeat dose
challenge
late asthmatic response

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014