Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash on Patient-Perceived Breathing Comfort
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Nasal Symptom Diary
研究概览
简要总结
Over 20 million Americans have allergic nasal symptoms including stuffiness, sneezing and a "runny" nose. AkPharma's Calcium Glycerophosphate used as a nasal spray wash is believed to improve these symptoms without side effects common to over the counter and prescription medication. It is hypothesized that Calcium Glycerophosphate will have a perceived improvement in breathing comfort.
详细描述
Subjects will be screened for inclusion and exclusion criteria and consented if they fit the same criteria. They will be instructed on keeping a nasal diary of symptoms "runny, itchy, congestion, sneezing, voice changes and throat clearing". They will have blood drawn for allergy testing. After a 1 week run-in, subjects will return their diary. If they still qualify based on the diary they will have baseline labs drawn and baseline breathing test (Spirometry) performed. They will also have a nasal wash and specimen collection performed. They will be instructed on use of the nasal wash. There will be three more weekly visits before study conclusion which will include diary submission, Spirometry and nasal wash and specimen collection. On the final visit blood will again be collected as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female 18-80 years of age
- •Twelve months or more of allergic rhinitis symptoms
- •Allergic antibodies to perennial aeroallergens to be confirmed by blood draw
排除标准
- •Intranasal or systemic glucocorticosteroids within one month of study entry
- •Intranasal cromolyn for 2 weeks prior to study
- •Intranasal or systemic antihistamine for 3 days prior to the study
- •Loratadine for ten days prior to study
- •History of rhinitis medicamentosa
- •Planned travel outside the study area that will inhibit study follow-up visits
- •_Persons with Asthma with more than 2 episodes per week or month of nighttime awakenings
- •Persons with Known sensitivity to Calcium or phosphorus supplements
- •Persons taking antihistamine treatment intermittently. (Chronic steady use throughout study is acceptable)
- •Immunomodulatory or cytotoxic drugs
- •Clinically significant uncontrolled disease that in the opinion of the investigator would put the subject at risk or may confound the study interpretation
- •Persons with hypercalcemia
- •Persons whose nasal obstruction(s) would be significant to obstruct air flow
- •Persons who are employees of Investigator or AkPharma or whose spouse, parent, child or sibling is employee of investigator
- •Pregnant persons or persons planning to conceive/inseminate partner during study or for one month after
结局指标
主要结局
Nasal Symptom Diary
时间窗: 28 days
Perceived improved comfort breathing is anticipated as primary outcome
次要结局
- Spirometry(21 days)