Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone propionate/salmeterol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Decrease in peripheral blood eosinophils.
Secondary outcome: Peripheral blood eosinophils
serum IL-51. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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 and Contacts
GSK Clinical Trials Call Center, Madison, Wisconsin 53792, United States; Recruiting
William Busse, MD, Phone: 877-379-3718
Additional Information
Starting date: August 2007
Ending date: October 2008
Last updated: February 28, 2008
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