A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Effect of Nasal Carbon Dioxide on Nasal Congestion Via Acoustic Rhinometry in Subjects With Perennial Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Capnia, Inc.
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determine the dose-related effects of CO2 on nasal congestion assessed by acoustic rhinometry.
研究概览
简要总结
The purpose of this study is to evaluate the effect of nasal CO2 on nasal congestion and other symptoms related to Perennial Allergic Rhinitis.
详细描述
A randomized study to evaluated the safety and effect of nasal carbon dioxide on nasal congestion using acoustic rhinometry in subjects with perennial allergic rhinitis. The acoustic rhinometry is an instrument that will be used to assess the levels of the nasal congestion in each subject. Approximately 20 men and women ages 19-65 years old who have a history consistent with perennial allergic rhinitis requiring pharmacology for at least 2 years and meet all other eligibility criteria will be enrolled in this study. There will be six (6) visits to the clinic. There will be a screening visit, four (4) treatment visits, and an end of study visit. A subject's participation in the study may last up to 58 days. There will be four different doses given in this study. Each subject will receive 3 different doses of the study drug and one dose of the placebo.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a history consistent with minimal 2 year history of perennial allergic rhinitis requiring pharmacotherapy.
- •Positive skin test to perennial allergens (e.g. cats, dogs, house dust mite, etc.)
- •Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test
排除标准
- •History of asthma (other than mild or intermittent)
- •Clinically significant nasal disorders
- •Acute or significant sinusitis or upper respiratory infection within 14 days of randomization
- •Have an existing serious medical condition (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
- •Use of certain medication s prior to randomization and during study participation
- •Participation in prior study with Nasal CO2
- •Participation in another clinical study within 30 days of planned randomization date and for the duration of the study
研究组 & 干预措施
1
The following treatment sequence: A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo)
干预措施: Nasal Carbon Dioxide (Drug)
2
The following treatment sequence: B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide)
干预措施: Nasal Carbon Dioxide (Drug)
3
The following treatment sequence: C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide)
干预措施: Nasal Carbon Dioxide (Drug)
4
The following treatment sequence: D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide)
干预措施: Nasal Carbon Dioxide (Drug)
结局指标
主要结局
Determine the dose-related effects of CO2 on nasal congestion assessed by acoustic rhinometry.
时间窗: Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours
次要结局
- Change from baseline in olfactory test scores post-treatment(Baseline, Post Treatment: 1 hour & 3 hours)
- TNSS, TNNSS, and TSS comparisons at multiple timepoints(Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, 24 hours)