An Open-label, Randomized, Parallel-Group, Multi-Site Study to Evaluate the Efficacy and Safety of Azelastine HCl-Fluticasone Propionate Nasal Spray 137-50 mcg/Spray in Perennial Allergic Rhinitis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 5
- 主要终点
- Change in reflective total nasal symptom scores (rTNSS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Azelastine HCl-Fluticasone propionate Nasal Spray 137-50 mcg/spray compared to Dymista™ in patients with perennial allergic rhinitis
详细描述
This study is an open label, randomized, parallel-group study to evaluate the efficacy and safety of azelastine/fluticasone 137/50 mcg nasal spray, to Dymista™ nasal spray in perennial allergic rhinitis (PAR) patients.
An estimated 200 evaluable subjects are planned for this study. Subjects who are at least 20 years of age with PAR and meet the eligibility criteria will be eligible for this study.
There will be a 7-day washout period to establish a baseline, followed by a 28-day treatment period. All subjects who qualify after the washout period will be randomized to receive the test formulation of azelastine/fluticasone or Dymista™ during the treatment period, administered as one spray in each nostril twice daily for 28 days.
Subjects will self-score their symptoms twice daily (AM and PM, approximately 12 hours apart at the same times daily) throughout the washout period and the treatment period. During the treatment period, scoring should be made immediately prior to each dose to reflect the previous 12 hours (reflective scores). The 4 symptoms evaluated are: runny nose, sneezing, nasal itching, and congestion. Each of the symptoms will be scored on a scale of 0 to 3, with 0 indicating absent symptoms and 3 indicating severe symptoms (symptoms that are hard to tolerate; causes interference with activities of daily living and/or sleeping).
The primary endpoint is the difference in the mean change in reflective total nasal symptom scores (rTNSS) from baseline to the end of the treatment period.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years of age and older.
- •For female subjects of childbearing potential: agreement to practice birth control for the duration of the study with either A. A birth control form with a failure rate of < 1%: intrauterine device, hormonal contraceptive and abstinence; or B. A combination of birth control forms resulting in a failure rate of < 1%: male condom, female condom or diaphragm in combination with another adequate form of birth control (intrauterine device, hormonal contraceptive, male condom, female condom or diaphragm).
- •A medical history consistent with AR as judged by the investigator.
- •Allergy to perennial allergen demonstrated by Multiple Antigen Simultaneous Test (MAST) or ImmunoCAP test (> or = Class 1) within 12 months of the screening visit or during screening as assessed by the investigator.
- •If receiving immunotherapy injections, on a stable regimen for at least 30 days prior to Visit
- •Immunotherapy injections are defined as controlled repetitive dosing of allergen(s) at regular intervals, in order to increase immune tolerance to the offending allergen(s).
- •In order to enter the washout period, a reflective TNSS score of at least 6 on Visit
- •In order to enter the treatment period, a Baseline reflective TNSS score of at least
- •The Baseline rTNSS is the mean of the rTNSS scores for the last 3 days of the washout period and the rTNSS score at the randomization visit.
- •Signed written informed consent.
排除标准
- •For females: Pregnancy, lactating, or planning to become pregnant during the study period.
- •Active or quiescent tuberculosis infections of the respiratory tract; Active and untreated local or systemic fungal, bacterial, viral, or parasitic infections within the 12months prior to the screening visit.
- •Presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis, or other eye infection within the 12 months prior to the screening visit.
- •Presence of any clinically significant nasal mucosal erosion, nasal septal ulcers, or septum perforation on focused nasal examination.
- •Nasal or sinus surgery or nasal trauma within the previous year likely to affect deposition of intranasal medication in the judgment of the investigator.
- •Other nasal disease(s) likely to affect deposition of intranasal medication, such as chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities (patients with severe nasal septum deviation, nasal stenosis or cleft lip and cleft palate).
- •Presence or history of any clinically significant condition that, in the judgment of the investigator, would compromise the safety of the subject or the conduct of the study.
- •Use of any investigational drug within 30 days prior to Visit
- •Hypersensitivity to azelastine hydrochloride, fluticasone propionate, or any inactive ingredients of the investigational product.
- •Respiratory tract infection requiring antibiotics within 14 days prior to Visit
- •Has clinically significant pulmonary disease, including asthma (with the exception of mild intermittent asthma) or chronic obstructive pulmonary disease (COPD).
- •Known history of alcohol, drug, or substance abuse in the 12 months prior to screening.
- •Use of any prohibited medications and treatments (including antihistamines, decongestants, leukotriene antagonists, corticosteroids and other nasal therapies,) within the time period specified in the protocol prior to Visit 2.
研究组 & 干预措施
azelastine hydrochloride and fluticasone propionate, 137/50 mcg
The test product, azelastine hydrochloride and fluticasone propionate, 137/50 mcg is manufactured by the sponsor, administered as one spray in each nostril twice daily for 28 days.
干预措施: azelastine/fluticasone 137/50 mcg nasal spray (Drug)
Dymista™
The active control product, Dymista™, is manufactured by Meda Pharmaceuticals, administered as one spray in each nostril twice daily for 28 days.
干预措施: Dymista™ (Drug)
结局指标
主要结局
Change in reflective total nasal symptom scores (rTNSS)
时间窗: 4 weeks
Subjects will self-score their symptoms twice daily (AM and PM, approximately 12 hours apart at the same times daily) throughout the washout period and the treatment period. During the treatment period, scoring should be made immediately prior to each dose to reflect the previous 12 hours (reflective scores). The 4 symptoms evaluated are: runny nose, sneezing, nasal itching, and congestion. Each of the symptoms will be scored on a scale of 0 to 3, with 0 indicating absent symptoms and 3 indicating severe symptoms (symptoms that are hard to tolerate; causes interference with activities of daily living and/or sleeping).
次要结局
- Nasal examinations(4 weeks)
- Adverse events(4 weeks)