NCT Number: NCT00380354
Study To Evaluate GSK256066 In Subjects With Mild Bronchial 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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
GSK Investigational Site, Manchester, Lancashire, United Kingdom
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Asthmatic response
Time frame: after 7 days of treatment
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
GlaxoSmithKline
Industry
Registry information
Official study 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
Important dates
- Study start
- 2006
- Study completion
- 2007
- First posted
- Sep 25, 2006
- Registry last updated
- Jun 4, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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