A Two-Part, Randomized Clinical Trial to Study the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
研究概览
简要总结
The purpose of this study is to evaluate the relationship between upper and lower airway allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2) cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive correlation between effects of prednisone versus placebo on Th2 cytokines in sputum and nasal exudates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Has a clinical history of mild to moderate asthma for at least 6 months, but otherwise is in good health
- •Participant with allergic rhinitis and asthma has a history of nonseasonal airway symptoms in response to aeroallergens OR has seasonal symptoms but can be evaluated out-of-season
- •Is clinically stable and free of respiratory infection or change in allergen exposure for at least 4 weeks prior to start of study
排除标准
- •Has intolerance to the study drug, inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication
- •Has intolerance to lidocaine/lignocaine, sedatives, atropine or glycopyrrolate, or any other medication associated with bronchoscopy
- •Has taken oral parenteral corticosteroids within 8 weeks or inhaled corticosteroids/nasal corticosteroids within 5 weeks of screening and/or during the study
- •Has recent (4 weeks) or ongoing upper or lower respiratory tract infection
- •Has active allergic rhinitis at screening
- •Has received a vaccination within 3 weeks of screening
研究组 & 干预措施
Placebo, then Prednisone
Placebo in the first crossover treatment period and prednisone in the second crossover treatment period
干预措施: Placebo (Drug)
Prednisone, then Placebo
Prednisone in the first crossover treatment period and placebo in the second crossover treatment period
干预措施: Prednisone (Drug)
Prednisone, then Placebo
Prednisone in the first crossover treatment period and placebo in the second crossover treatment period
干预措施: Placebo (Drug)
Placebo, then Prednisone
Placebo in the first crossover treatment period and prednisone in the second crossover treatment period
干预措施: Prednisone (Drug)
结局指标
主要结局
Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
时间窗: Baseline and 7 hours post-allergen challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-13 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.
Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
时间窗: Baseline and 7 hours post-allergen challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, nasal exudates (NE) and sputum (SP) were collected, then the concentrations of IL-5 were determined from NE and SP collected after 7 hours and previously at baseline (BL), to derive the fold change (FC) from BL for each participant. The geometric mean (GM) was determined by averaging FC from BL for all analyzed participants.
次要结局
- Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge(Baseline and 7 hours post-allergen challenge)
- Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge(Baseline and 7 hours post-allergen challenge)
- Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge(Baseline and 7 hours post-allergen challenge)
- Change in Vibration Response Imaging (VRI) After Metacholine Exposure(From 1 to 7 hours post-allergen challenge)
- Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge(Baseline and 7 hours post-allergen challenge)
- Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge(Baseline and 7 hours post-allergen challenge)
- Geometric Mean Fold Change From Baseline in Interleukin-23 (IL-23) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge(Baseline and 7 hours post-allergen challenge)
- Geometric Mean Fold Change From Baseline in Nasal and Bronchial Eicosanoids and Leukotrienes at 7 Hours Post-allergen Challenge.(Baseline and 7 hours post-allergen challenge)
- Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge(Baseline and 7 hours post-allergen challenge)
- Geometric Mean Fold Change From Baseline in Thymic Stromal Lymphopoietin (TSLP) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge(Baseline and 7 hours post-allergen challenge)
- Geometric Mean Fold Change From Baseline in Cytokines From Bronchoalveolar Lavage Fluid (BALf)(Baseline and 23 hours post-allergen challenge)