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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: FF/Vilanterol (VI; GW642444M); Drug: Placebo; Drug: Fluticasone Furoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01128569

113090

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

52 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Inhaler

Treatment:

Drug: Placebo

inhaled corticosteroid(ICS)/long acting bronchodilator (LABA)

Active Comparator group

Description:

ICS/LABA inhaler

Treatment:

Drug: FF/Vilanterol (VI; GW642444M)

ICS

Active Comparator group

Description:

ICS inhaler

Treatment:

Drug: Fluticasone Furoate