A Double-Blind Placebo-Controlled Crossover Study to Evaluate Objective Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure in an Environmental Exposure Unit

Bayer1 个研究点分布在 1 个国家目标入组 82 人开始时间: 2018年2月21日最近更新: 2019年12月20日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Bayer
入组人数: 82
试验地点: 1
主要终点: Average percent change in PNIF (Peak Nasal Inspiratory Flow) from 0 to 4 hours after dosing

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Healthy, ambulatory male and female subjects between 18 to 65 years of age
•Self-reported seasonal allergic rhinitis to ragweed pollen for at least 2 years prior to screening
•Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen at screening or within the previous 12 months conducted at research site (prick with wheal diameter >= 5 mm larger than the diluent response)
•In order to qualify to continue to treatment phase, at the end of priming phase (which is 3 hours), Total Symptom Score (TSS) has to be ≥ 7, with nasal congestion score alone ≥ 2 and change in peak nasal inspiratory flow (PNIF) has to be ≥ 15% from pre-prime baseline;
•Subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to priming and during the trial
•At the discretion of the investigators, subjects may be considered with self-reported mild intermittent asthma (Using <=2 doses of SABA (short-acting beta agonists) per week) or exercise-induced asthma
•Subject is free of any clinically significant disease that required a physician´s care and/or would interfere with trial evaluations, procedures or participation
•Subject is able to repeatedly and reliably perform PNIF measurements and must achieve PNIF value of >=60L/min at screening
•Subject must be capable of reading English and willing to participate in all aspects of the study

排除标准

•Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, pseudoephedrine and fluticasone propionate, or might interfere with the trial. These may include subjects with injury or surgery to the nose that is not fully healed, fungal infections, immunocompromised conditions (HIV, tuberculosis), severe nosebleeds, narrow-angle glaucoma, chickenpox measles..., severe facial pain or thick nasal discharge, sinusitis, constant whistling sound from the nose, structured abnormality of the nose, uncontrolled thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease ischemic heart disease, uncontrolled high blood pressure, symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, renal disease