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
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent.
- •Outpatient.
- •Male or non-pregnant/non-lactating female.
- •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 CYP3A
- •Respiratory tract infection.
- •Asthma exacerbation with 4 weeks of Visit
- •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.
Arms & Interventions
Sequence 2: Placebo, SFC, FP
Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Intervention: Placebo
Sequence 1: FP, SFC, Placebo
Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
Intervention: FP
Sequence 1: FP, SFC, Placebo
Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
Intervention: SFC
Sequence 1: FP, SFC, Placebo
Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
Intervention: Placebo
Sequence 2: Placebo, SFC, FP
Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Intervention: FP
Sequence 2: Placebo, SFC, FP
Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Intervention: SFC
Sequence 3: SFC, FP, Placebo
Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
Intervention: FP
Sequence 3: SFC, FP, Placebo
Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
Intervention: SFC
Sequence 3: SFC, FP, Placebo
Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
Intervention: Placebo
Sequence 4: SFC, Placebo, FP
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Intervention: FP
Sequence 4: SFC, Placebo, FP
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Intervention: SFC
Sequence 4: SFC, Placebo, FP
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Intervention: Placebo
Sequence 5: FP, Placebo, SFC
Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Intervention: FP
Sequence 5: FP, Placebo, SFC
Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Intervention: SFC
Sequence 5: FP, Placebo, SFC
Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Intervention: Placebo
Sequence 6: Placebo, FP, SFC
Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Intervention: FP
Sequence 6: Placebo, FP, SFC
Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Intervention: SFC
Sequence 6: Placebo, FP, SFC
Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Intervention: Placebo
Outcomes
Primary Outcomes
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35
Time Frame: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35
Number of peripheral blood eosinophils measured from blood draws
Secondary Outcomes
- Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14(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(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(0-6 hours post allergen challenge, 1 hour after dosing, Day 14)