Official Title: “See Detailed Description”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2008

A 19-week, randomized, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate 50/100mcg BID, fluticasone propionate 100mcg BID and placebo on blood markers of airway inflammation in response to allergen challenge in asthma subjects

Intervention(s) in this Clinical Trial

• Drug: fluticasone propionate/salmeterol

Primary Measures

• Decrease in peripheral blood eosinophils.

Secondary Measures

• Peripheral blood eosinophils serum IL-5
• 1. Weighted mean change from baseline over 0-6 hours post allergen challenge in serum IL-5 on Day 35.
• 2. Weighted mean change from baseline over 0-6 hours post allergen challenge in blood eosinophils and serum IL-5 on Day 35.
• 3. Weighted mean change from baseline over 0-6 hours post allergen challenge in blood eosinophils and serum IL-5 on Day 14.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00517634

Study ID Number: HZA109912

ClinicalTrials.gov Identifier: NCT00517634

Health Authority: United States: Food and Drug Administration