Steroid Treatment for Elimination of Rebound Obstruction From Intranasal Decongestants
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Responder rate
研究概览
简要总结
This prospective, virtually administered trial conducted throughout the United States aims to evaluate a standardized protocol including the serial dilution of topical decongestants with concurrent topical steroids (triamcinolone), for elimination of dependence on topical decongestants.
详细描述
Participants will begin the trial by providing their average daily usage of oxymetazoline. They will then be stratified according to this usage and will be placed into a titration schedule. In the first week of the trial they will continue their usage of oxymetazoline plus twice daily triamcinolone intranasal spray. Continuing twice daily triamcinolone intranasal spray, the oxymetazoline dosage will be decreased each week until it matches the triamcinolone frequency. Each week following this point the subjects will continue with a mixture of different concentrations of oxymetazoline till complete elimination.
The maximum treatment time for participants who start the trial in the highest frequency oxymetazoline use group (greater than or equal to 5 times per day) would be 8 weeks.
After a week on a given titration level, they will be assessed for severity of nasal obstruction and, if controlled, they will progress to the next titration.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2) have a history of chronic nasal obstruction 3) at least daily topical decongestant usage for at least 3 months 4) ability to read, write, and understand English.
排除标准
- •Any history of sinonasal mass/tumor
- •Any history of nasal polyps
- •Septal perforation
- •A diagnosis of one of the following conditions:
- •eosinophilic granulomatosis with polyangiitis
- •granulomatosis with polyangiitis
- •Any current intranasal drug use such as cocaine.
- •If they are currently using or have used intranasal steroid medications (oral or nasal) besides oxymetazoline for the past month.
研究组 & 干预措施
Titration
Participants will begin the trial by providing their average daily usage of oxymetazoline.
They will then be stratified according to this usage and placed into a titration schedule. After a week on a given titration level, they will be assessed for severity of nasal obstruction and, if controlled, they will progress to the next lower titration level.
Participants with twice daily use, will then be placed in a titration schedule for oxymetazoline concentration which will stop when the oxymetazoline concentration is set to zero.
干预措施: Oxymetazoline + Triamcinolone (Drug)
结局指标
主要结局
Responder rate
时间窗: week 8
The primary outcome measure will be the responder rate, defined as the percentage of participants who are able to discontinue decongestant use by the end of the study period and report that their symptoms are well-controlled, indicated by a score of 4 or less on the CGI-S.
次要结局
- Responder rate among supratherapeutic users.(week 8)
- The rate of partial responders among supratherapeutic users(week 8)
- Change in Nasal Obstruction Symptom Evaluation (NOSE)(through study completion, on average of 8 weeks)