NCT01368445已完成3 期
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Patients With Seasonal Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 30
- 主要终点
- Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo
研究概览
简要总结
The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 12 years of age and older
- •Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
- •Screening Visit: Have a 12-hour reflective total nasal symptoms score ( TNSS) of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
- •Randomization Visit: Have a 12-hour reflective total nasal symptoms score (TNSS) (AM or PM) of at least 8 on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM nasal congestion score of 2 or 3 must have been recorded on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1).
- •Must have taken at least 10 doses of study medication during the lead-in period
- •Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset of action assessment on Day 1
- •Willing and able to comply with the study requirements
- •At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollen allergy season
- •The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by a positive response to either skin prick or intradermal testing within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the control for the skin prick test or at least 7 mm larger than the control for the intradermal test.
- •General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
- •Patients receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation). Patients who are on maintenance doses of sublingual immunotherapy may be considered for the trial on a case-by-case basis after discussion with the sponsor's medical monitor or designee.
排除标准
- •The use of any investigational drug within 30 days prior to Day -
- •No investigational products are permitted for use during the conduct of this study
- •Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
- •Women who are pregnant or nursing
- •Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- •Respiratory tract infections within two weeks prior to Day -7
- •Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7
- •Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities
- •Patients with asthma (with the exception of mild, intermittent asthma)
- •Patients with significant pulmonary disease
- •Patients with a known history of alcohol or drug abuse
- •Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug
- •Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
- •Planned travel outside the study area during the study period
- •Family members and employees should be excluded
- •Patients who received prohibited medications within specified timepoints in the protocol.
研究组 & 干预措施
MP03-36 Nasal Spray
Active Comparator
azelastine hydrochloride 0.15%
干预措施: azelastine hydrochloride 0.15% Nasal Spray (Drug)
MP03-36 and Placebo Nasal Spray
Active Comparator
azelastine hydrochloride 0.15% and Placebo
干预措施: azelastine hydrochloride 0.15% and Placebo (Drug)
Azelastine 0.1%, Nasal Spray
Active Comparator
Azelastine 0.1%, Nasal Spray
干预措施: Azelastine 0.1%, Nasal Spray (Drug)
Placebo Nasal Sapray
Placebo Comparator
0mg, 2 sprays per nostril twice daily AM & PM)
干预措施: azelastine hydrochloride 0.15% Nasal Spray (Drug)
Placebo Nasal Sapray
Placebo Comparator
0mg, 2 sprays per nostril twice daily AM & PM)
干预措施: azelastine hydrochloride 0.15% and Placebo (Drug)
Placebo Nasal Sapray
Placebo Comparator
0mg, 2 sprays per nostril twice daily AM & PM)
干预措施: Azelastine 0.1%, Nasal Spray (Drug)
结局指标
主要结局
Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo
时间窗: 14 Days
次要结局
- Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo(14 Days)
- Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo(14 Days)
- Change From Baseline on Direct Visual Nasal Exams(14 Days)
研究者
研究点 (30)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential HypertensionHypertensionNCT00696241Takeda1,275
已完成
2 期
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergic RhinitisAllergic RhinitisNCT06051786Synmosa Biopharma Corp.136
已完成
3 期
Fixed-Dose Trial in Early Parkinson's Disease (PD)Parkinson DiseaseNCT04201093AbbVie529
已完成
2 期
Study of PH3 for the Prevention of Osteoporosis in Postmenopausal WomenOsteoporosisNCT00693667PhytoHealth Corporation92
终止
3 期
Efficacy, Safety and Tolerability of Pioglitazone-Azilsartan in Subjects With Type 2 Diabetes MellitusType 2 DiabetesNCT00376181Takeda96