A Double-Blind, Parallel, Randomized, Placebo Controlled Trial to Evaluate Onset of Action of Loratadine and Fexofenadine in Subjects With Seasonal Allergic Rhinitis in a Pollen Challenge Chamber
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 255
- 主要终点
- Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
研究概览
简要总结
The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and
Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female participants of child bearing potential must demonstrate a negative
- •urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study.
- •Willing to stop use of current decongestant and allergy medications at the start of the washout period (Visit 1) and during the trial.
- •Documented history or participant-reported history of seasonal allergic rhinitis caused by mountain cedar pollen within the last 2 years and documented or participant-reported symptoms over at least the last 2 mountain cedar allergy seasons.
- •Documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the last 1 year to mountain cedar pollen present.
- •Capable of reading English.
- •Body mass index (BMI) <35.
排除标准
- •Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, fexofenadine or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.
- •Have started allergen immunotherapy within 1 month preceding enrollment or participants starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.
- •Known allergy or intolerance to loratadine, desloratadine, or fexofenadine.
- •History of rhinitis medicamentosa.
- •Use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone is permitted), or nasal corticosteroids in the last 30 days or current or expected use of disallowed medications as listed in the protocol.
- •Asthma, with the exception of mild intermittent asthma.
研究组 & 干预措施
loratadine
Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
干预措施: loratadine (Drug)
placebo
Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.
干预措施: placebo to loratadine (Drug)
loratadine
Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
干预措施: placebo to fexofenadine (Drug)
fexofenadine
Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
干预措施: fexofenadine (Drug)
fexofenadine
Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
干预措施: placebo to loratadine (Drug)
placebo
Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.
干预措施: placebo to fexofenadine (Drug)
结局指标
主要结局
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
时间窗: From time of sensitization (time 0) to end of visit (~8 hours)
The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.
次要结局
- Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point(From time of sensitization (time 0) to end of visit (~8 hours))
- Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point(From time of sensitization (time 0) to end of visit (~8 hours))
- Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point(From time of sensitization (time 0) to end of visit (~8 hours))
- Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point(From time of sensitization (time 0) to end of visit (~8 hours))
- Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point(From time of sensitization (time 0) to end of visit (~8 hours))
- Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point(From time of sensitization (time 0) to end of visit (~8 hours))
- Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point(From time of sensitization (time 0) to end of visit (~8 hours))