Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS) combination product on protection from allergic triggers in asthma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

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