Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

GlaxoSmithKline23 enrolled

Overview

The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.

A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

FPDRUG

Fluticasone Propionate 100 mcg BD

SFCDRUG

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

PlaceboDRUG

Matching Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent. * Outpatient. * Male or non-pregnant/non-lactating female. * Aged 18-55. * Diagnosis of asthma. * Pre-bronchodilatory FEV1 \> 75% predicted. * Using inhaled short-acting beta-2-agonists (SABA) with no inhaled corticosteroids. * Judged capable of withholding SABA for at least 6 hours prior to visits. * Reversibility of \>12% and 200mL or PC20 of \<8mg/mL. * Demonstration of atopy Exclusion Criteria: * History of life-threatening asthma. * Use of proscribed asthma medications. * Use of anti-histamines or potent inhibitors of CYP3A4. * Respiratory tract infection. * Asthma exacerbation with 4 weeks of Visit 1. * Subjects with exercise induced asthma only. * Concurrent respiratory disease. * Other clinically significant, uncontrolled condition or disease. * Use of any investigational drug within 30 days. * Allergic to beta-2-agonists, inhaled corticosteroids or excipients. * Positive pregnancy test. * Using immunosuppressive medications. * Milk protein allergy. * Factors likely to interfere with attendance. * Current smokers or ex-smokers with a history of \>10 pack years. * Affiliation wih Investigator site. * Medications that may affect the course of asthma or interact with sympathomimetic amines.

Locations (2)

GSK Investigational Site

Madison, Wisconsin, United States

GSK Investigational Site

Manchester, United Kingdom

Outcomes

Primary Outcomes

Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35

Number of peripheral blood eosinophils measured from blood draws

Time frame: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35

Secondary Outcomes

Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14

Number of peripheral blood eosinophils measured from blood draws

Time frame: 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14

Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35

Amount of serum interleukin (IL)-5 measured from blood draws

Time frame: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35

Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14

Amount of serum IL-5 measured from blood draws

Time frame: 0-6 hours post allergen challenge, 1 hour after dosing, Day 14

Data from ClinicalTrials.gov

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