Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response

Launched by GLAXOSMITHKLINE · May 20, 2010

Keywords

ClinConnect Summary

Asthma is an increasingly common disease and is essentially caused by an allergic type of reaction of the immune system. Airways of the lungs become inflamed and narrow as a result of a reaction to triggers like chemicals (house-hold cleaning products, pollution) and allergens (house dust mite and cat or dog fur). The airways become blocked, causing shortness of breath and wheezing. The purpose of this study is to find out more information about how effective the study drugs are at protecting the lungs against allergic triggers of asthma. There are three study drugs being investigated in th...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
• • Females of non-child bearing potential.
• • 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 \>70% of predicted at screening
• • Subjects who are current non-smokers
• • Methacholine challenge PC20 \< 8 mg/mL at screening
• • Screening allergen challenge demonstrates that the subject experiences an early asthmatic response
• Exclusion Criteria:
• • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
• • Subject is hypertensive at screening
• • Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
• • History of life-threatening asthma
• • Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
• • Unable to abstain from short acting beta agonists
• • Unable to abstain from antihistamines
• • Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication
• • 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
• • undergoing allergen desensitisation therapy