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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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.
研究组 & 干预措施
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
干预措施: Placebo (Drug)
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
干预措施: FP (Drug)
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
干预措施: SFC (Drug)
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
干预措施: Placebo (Drug)
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
干预措施: FP (Drug)
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
干预措施: SFC (Drug)
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
干预措施: FP (Drug)
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
干预措施: SFC (Drug)
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
干预措施: Placebo (Drug)
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
干预措施: FP (Drug)
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
干预措施: SFC (Drug)
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
干预措施: Placebo (Drug)
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
干预措施: FP (Drug)
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
干预措施: SFC (Drug)
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
干预措施: Placebo (Drug)
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
干预措施: FP (Drug)
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
干预措施: SFC (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35
时间窗: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35
Number of peripheral blood eosinophils measured from blood draws
次要结局
- 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)