- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00380354
Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma
May 31, 2012 updated by: GlaxoSmithKline
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SE1 9RT
- GSK Investigational Site
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Lancashire
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Manchester, Lancashire, United Kingdom, M23 9LT
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Asthmatic response
Time Frame: after 7 days of treatment
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after 7 days of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
FEV1 Concentration of exhaled nitric oxide
Time Frame: on day 8 of each treatment period
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on day 8 of each treatment period
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Incidence of treatment emergent adverse events
Time Frame: throughout study
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throughout study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
September 21, 2006
First Submitted That Met QC Criteria
September 21, 2006
First Posted (Estimate)
September 25, 2006
Study Record Updates
Last Update Posted (Estimate)
June 4, 2012
Last Update Submitted That Met QC Criteria
May 31, 2012
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 4 Inhibitors
- 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Other Study ID Numbers
- IPA101985
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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