Overview

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