Mild asthma MedDRA version: 9.1 Level: LLT Classification code 10001705 Term: Allergic asthma
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18 to 55 years inclusive. 2. Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2). 3. Female subjects must be of non childbearing potential. 4. Male subjects must agree to use one of the contraception methods listed in Section 8.1 of the protocol. 5. 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. 6. Pre-bronchodilator FEV1 >70% of predicted at screening. 7. Subjects who are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit. 8. Demonstration of a positive wheal and flare reaction (> 3 mm relative to negative control) to at least one allergen from a battery of allergens on skin prick testing. 9. Methacholine challenge PC20 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Past or present disease, which as judged by the investigator or medical monitor, may affect the outcome of this study. 2. Clinically significant abnormalities in safety laboratory analysis at screening. 3. Subject has known history of hypertension or is hypertensive at screening. 4. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. 5. History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. 6. Symptomatic with hay fever at screening or predicted to have symptomatic hayfever during the time of study. 7. Administration of oral or injectable steroids within 5 weeks of screening or intranasal and/or inhaled steroids within 4 weeks of the screening visit. 8. Unable to abstain from other medications including non-steroidal anti- inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti- asthma, anti-rhinitis or hay fever medication. 9. If, after 2 concurrent administrations of saline during the allergen challenge at screening the subjects still have a fall in FEV1 of greater than 10%. 10.The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months prior to the first dosing day. 11.History of being unable to tolerate or complete methacholine and/or allergen challenge tests. 12.The subject has a screening QTc value of >450msec, PR interval outside the range 120 to 220msec or an ECG that is not suitable for QT measurements. 13.The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen. 14.The subject has tested positive for HIV antibodies. 15.The subject has a positive pre-study urine cotinine/ breath carbon monoxide test or urine drug or urine or breath alcohol screen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of treatment with repeat oral doses of GSK2190915 on the early asthmatic response (EAR) to inhaled allergen in mild asthmatic subjects compared with placebo;Secondary Objective: • To evaluate the effect of treatment with repeat oral doses of GSK2190915 on lung function as measured by FEV1 on Days 1 and 3 in subjects with mild asthma compared with placebo • To assess the safety and tolerability of repeat oral doses of GSK2190915 in mild asthmatic subjects compared with placebo ;Primary end point(s): Early Asthmatic Response: Minimum FEV1 absolute change from baseline between 0-2 hours after allergen challenge on Day 3 of each treatment period | — |
Countries
United Kingdom
Outcome results
None listed