A Phase IIIb, Single-center, Double-blind, Two-arms, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of 2-day Pre-treatment With Fexofenadine in Patients Suffering From Seasonal Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3)
研究概览
简要总结
This study is a proof-of-concept study to demonstrate if a daily dose of a 2-days pre-treatment of Fexofenadine 180mg is effective in alleviating the AR symptoms and to assess the additional benefit to the patient in terms of preventing Allergic Rhinitis (AR) symptoms.
The total study duration per participant is expected at least 4 months, depending on the timing of the screening visit. 5 visits are planned, screening, confirmation inclusion challenge, randomization visit, challenge and end of study visit.
详细描述
The end of the study is defined as the date of the last visit of the last participant in the study.
A participant is considered to have completed the study if he/she has completed all visits of the study including Visit 5 (Day 5).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Participant is willing to provide written informed consent.
- •Adult participants (18 to 80 years old) suffering from seasonal allergic rhinitis (SAR) provoked by Ragweed pollen.
- •Participants having a total nasal symptom score (TNSS)-3 ≥4 (with 3 nasal symptoms) at first pollen challenge at Visit
- •Having a 2-year history of SAR with Positive skin prick test to Ragweed allergen at screening (with a wheal diameter at least 3 mm larger than that produced by the negative control).
排除标准
- •History of anaphylaxis to Ragweed pollen History of asthma or exacerbations in the past 12 months requiring regular inhaled corticosteroids for greater than 4 weeks per year, any oral corticosteroid usage, any emergency department visit for asthma or any asthma-related hospitalization. Mild asthmatics treated only with pro re nata short-acting β2agonists, less than 2 doses per week can be enrolled.
- •History of chronic sinusitis, defined as a sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
- •History of systemic disease affecting the immune system such as autoimmune diseases, immune complex disease, or immunodeficiency, where, in the opinion of the study physician, participation in the trial would pose a risk or significant effect on the immune system.
- •Presence or history of drug hypersensitivity to fexofenadine and/or its excipients.
- •Participants unable to stop the following forbidden treatments/nutriments prior to pollen challenge:
- •Antihistamines: within 3 days for first-generation antihistamines, within 2 days for second-generation antihistamines.
- •Intranasal or inhaled corticosteroids: 7 days.
- •Ocular, intranasal, or inhaled sodium cromoglycate: 14 days.
- •High doses of systemic corticosteroids: 30 days.
- •Leukotriene antagonists: 30 days.
- •Intranasal or systemic decongestants: 3 days.
- •Tricyclic antidepressants: 7 days.
- •Any citrus fruits (grapefruit, orange, etc.) or their juices, as well as all fruit juices: 5 days.
- •Aluminum-and-magnesium containing antacids: 7 days.
- •Omalizumab/dupilumab: within 6 months
- •Any contraindications to fexofenadine, according to the labeling.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Arm A (active-active)
Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
干预措施: Fexofenadine (Drug)
Arm B (placebo-active)
Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3)
时间窗: From 0 hour to 6 hours at Day 4
TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC \[0-6 hr\]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.5; Arm B=2.1-39.9.
次要结局
- AUC of Total Nasal Symptoms Score (TNSS-3) (H0-H12 at Day 4)(From 0 hour to 12 hours at Day 4)
- AUC of Total Ocular Symptoms Score (TOSS) (H0-H6 at Day 4)(From 0 hour to 6 hours at Day 4)
- AUC of Total Ocular Symptoms Score (TOSS) (H0-H12 at Day 4)(From 0 hour to 12 hours at Day 4)
- AUC of Total Ocular Symptoms Score (TOSS) (Day 1 to Day 4)(From randomization (Day 1) to Day 4)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)(From Day 2 to Day 5)
- AUC of Total Nasal Symptoms Score (TNSS-3) (Day 1 to Day 4)(From randomization (Day 1) to Day 4)