The Effects of Desloratadine and Levocetirizine on Nasal Obstruction in Subjects With Induced Allergic Rhinitis in the VCC Assessed Clinically and With Nasal Rhinomanometry and Nasal Flowmetry
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Change in Total Nasal Symptom Score (TNSS) at the end of treatment phase compared to pre-exposure baseline scores
研究概览
简要总结
This was a study to measure the ability of desloratadine and levocetirizine to decrease nasal obstruction in subjects who had study-induced allergic rhinitis. Study participants had allergic rhinitis symptoms induced in a Vienna Challenge Chamber and then received desloratadine or levocetirizine for 8 days. After at least a 10 to 35-day washout period (time when no drug is given), subjects received the opposite treatment for 8 days. Subjects had their total nasal symptom measured.on the 8th day of each treatment period.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 45 years of age
- •Were free of any clinically significant disease that would interfere with study evaluations.
- •Demonstrated hypersensitivity to the grass allergen used in the chamber unless confirmed previously within 12 months.
- •Hypersensitivity to the allergen was documented by a positive response to the skin prick test with a wheal diameter at least 3 mm larger than the diluent control and by a radioallergosorbent test (RAST) class of >=2 (rating scale 0 -6).
- •Had a history of SAR for at least 2 years, as diagnosed by the investigator, another physician, or subject-provided history.
- •Reported having shown therapeutic efficacy with previous use of an antihistamine (without a decongestant).
- •At the screening allergen provocation, the subject had a nasal obstruction symptom severity score of at least moderate (>=2) and a decrease from baseline in nasal airflow (mL/sec) measured by rhinomanometry of >=30% within 2 hours of allergen exposure. Also, the subject had a nasal obstruction symptom severity score of none or mild (<=1) prior to exposure to allergen.
排除标准
- •Women who were pregnant or nursing.
- •Had a body mass index (BMI) >=30 kg/m^
- •Had asthma; were being treated with inhaled or oral corticosteroids, chromones, theophylline, leukotriene inhibitors, or short-acting inhaled β2-agonists (except during or immediately after the allergen exposures); and could not go through the washout periods and the entire study without needing these medications.
- •Developed wheezing or dyspnea during the screening allergen exposure.
- •Had a respiratory infection during the 4 weeks prior to pre-dose evaluations.
- •Had any clinically significant deviation from normal in the physical examination that, in the investigator's judgment, could interfere with the study evaluation or affect subject safety.
- •Had any history of or laboratory evidence of hepatic failure or renal failure with a glomerular filtration rate (GFR) known to be <30 mL/min.
- •Had a known potential for hypersensitivity, allergic, or idiosyncratic reaction to the study drug or excipients.
- •Had nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interfered with nasal airflow.
研究组 & 干预措施
desloratadine followed by levocetirizine
Subjects in this arm received desloratadine 5 mg daily for 8 days, followed by 10 day washout period, then followed by levocetirizine 5 mg daily for 8 days
干预措施: desloratadine (Drug)
desloratadine followed by levocetirizine
Subjects in this arm received desloratadine 5 mg daily for 8 days, followed by 10 day washout period, then followed by levocetirizine 5 mg daily for 8 days
干预措施: levocetirizine (Drug)
levocetirizine followed by desloratadine
Subjects in this arm received levocetirizine 5 mg daily for 8 days, followed by 10 day washout period, then followed by desloratadine 5 mg daily for 8 days
干预措施: desloratadine (Drug)
levocetirizine followed by desloratadine
Subjects in this arm received levocetirizine 5 mg daily for 8 days, followed by 10 day washout period, then followed by desloratadine 5 mg daily for 8 days
干预措施: levocetirizine (Drug)
结局指标
主要结局
Change in Total Nasal Symptom Score (TNSS) at the end of treatment phase compared to pre-exposure baseline scores
时间窗: End of each treatment phase (8th day)
次要结局
- Safety(All study visits)
- Nasal Peak Inspiratory Flow (NPIF), Nasal secretion weights, nasal airflow, individual nasal symptoms, TNSS, Total Non-Nasal Symptoms Severity Score (TNNSS), Total Symptom Score (TSS)(End of each treatment phase (8th day))