Randomized Controlled Trial Evaluating Combination Rupatadine and Fluticasone Propionate Compared to Azelastine Hydrochloride and Fluticasone Propionate in Treating Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change in Reflective Total Nasal Symptom Score (TNSS)
研究概览
简要总结
Combination pharmacotherapy is often used in people who have failed mono-therapies in managing their bothersome allergic rhinitis symptoms . However, there is a paucity of research indicating the most effective combination therapies in managing allergic rhinitis. This study aims to evaluate the efficacy of oral antihistamine (rupatadine) combined with nasal steroid (fluticasone propionate) compared to a well-studied combination therapy of nasal steroid with nasal antihistamine spray (MP-AzeFlu).
详细描述
Allergic rhinitis is a common inflammatory disorder of the nose that is increasing in prevalence worldwide. Symptoms of allergic rhinitis has a significant negative impact on an individual's quality of life. When the symptoms are not well managed with allergen avoidance and first line pharmacotherapies, patients often resort to using a combination of medications. Physicians may recommend combination therapies to patients with moderate-to-severe allergic rhinitis, however, there is a scarcity of research indicating efficacy of combination therapy use. The investigators of this study aim to evaluate the efficacy of combining oral antihistamine (rupatadine) with nasal steroid (fluticasone propionate) compared to a well-studied combination therapy of nasal steroid with nasal antihistamine spray (MP-AzeFlu) in people suffering from medium-to-severe allergic rhinitis. Oral rupatadine is a potent antihistamine and platelet activating factor (PAF) antagonist, which has not been studied in combination therapy in allergic rhinitis. Fluticasone propionate is a well established, first line nasal steroid.
Adults 19 years or older, seen in the Principal Investigator's office presenting with moderate-to-severe allergic rhinitis will be identified by the principal investigator and invited to participate in this prospective study. Patients will be recruited into the study in a consecutive manner. After providing consent, baseline characteristics will be collected. The investigator aims to recruit 51 patients in each study group respectively. Descriptive statistics will be used to analyze the baseline characteristic data.
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
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient over the age of 18
- •Positive allergy skin prick test that diagnose AR
- •Persistent and Moderate-to-Severe AR (Persistent symptoms for more than 6 weeks and suffers from abnormal sleep, impairment of daily activities, work-school problems, or has troublesome symptoms; TNSS of at least 8/12)
- •Negative CT sinus
排除标准
- •Non-Allergic Rhinitis patients will be excluded from this study.
- •Participants who are pregnant or lactating
- •Hypersensitivity to FP, MP-AzeFlu, or Rupatadine
- •Superficial or moderate nasal erosion, nasal mucosal ulceration or nasal septum perforation, who had nasal surgery within the last year, had significant pulmonary disease (excluding intermittent asthma)
- •Participants who had inferior turbinate reduction surgery
- •Participants who smoke
- •Not able to read and understand the consent form
- •Patients suffering from nonallergic rhinitis (eg. vasomotor, infectious, or drug-induced rhinitis) or with a negative skin prick test will not be included
研究组 & 干预措施
Dymista (Azelastine hydrochloride and fluticasone propionate)
Participants will receive standard of care, which includes twice daily MP-AzeFlu nasal spray (formulation of 137 mg of azelastine hydrochloride and 50 mcg of fluticasone propionate per spray) separated by 12 hours.
干预措施: Azelastine hydrochloride and fluticasone propionate (Drug)
Fluticasone Propionate and Rupatadine
Participants will administer fluticasone propionate nasal spray once daily (2 sprays in each nostril, 50 mcg fluticasone propionate per spray)and 1 tablet of Rupatadine (10mg) once daily in the morning.
干预措施: Fluticasone Propionate (Drug)
Fluticasone Propionate and Rupatadine
Participants will administer fluticasone propionate nasal spray once daily (2 sprays in each nostril, 50 mcg fluticasone propionate per spray)and 1 tablet of Rupatadine (10mg) once daily in the morning.
干预措施: Rupatadine (Drug)
结局指标
主要结局
Change in Reflective Total Nasal Symptom Score (TNSS)
时间窗: 2 weeks
Score range of 0 to 12, higher scores indicate worse symptoms
次要结局
- Adverse Events(2 weeks)
- Change in Individual reflective nasal symptoms score (iTNSS)(2 weeks)
- Change in reflective total ocular symptoms score (rTOSS)(2 weeks)
- Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(6 weeks)
研究者
Dr. Andrew Thamboo, MD
Principal Investigator
St. Paul's Sinus Centre
