Antitussive Effect of a Naturally Flavored, Multi-Component Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Cough Reflex Sensitivity to Capsaicin
研究概览
简要总结
The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa flavoring, and, dextromethorphan syrup, compared with 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
- Double (Participant, Investigator)
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
- •healthy adult nonsmokers
- •onset of acute, viral upper respiratory tract infection (common cold) within 72 hours of enrollment
排除标准
- •history of asthma or other respiratory disorders
研究组 & 干预措施
A, B, then C
Subjects received the following: Period 1: single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A). Period 2: dextromethorphan syrup 30 mg (treatment B); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo (Drug)
A, B, then C
Subjects received the following: Period 1: single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A). Period 2: dextromethorphan syrup 30 mg (treatment B); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan (Drug)
A, B, then C
Subjects received the following: Period 1: single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A). Period 2: dextromethorphan syrup 30 mg (treatment B); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo (Drug)
A, B, then C
Subjects received the following: Period 1: single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A). Period 2: dextromethorphan syrup 30 mg (treatment B); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa (Drug)
A, B, then C
Subjects received the following: Period 1: single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A). Period 2: dextromethorphan syrup 30 mg (treatment B); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan (Drug)
A, B, then C
Subjects received the following: Period 1: single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A). Period 2: dextromethorphan syrup 30 mg (treatment B); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa (Drug)
A, C, then B
Subjects received the following: Period 1: single oral doce of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A); Period 2: placebo liquid, dextrose in watwer, 20 mL (treatment C); Period 3: dextromethorphan syrup 30 mg (treatment B).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo (Drug)
A, C, then B
Subjects received the following: Period 1: single oral doce of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A); Period 2: placebo liquid, dextrose in watwer, 20 mL (treatment C); Period 3: dextromethorphan syrup 30 mg (treatment B).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan (Drug)
A, C, then B
Subjects received the following: Period 1: single oral doce of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A); Period 2: placebo liquid, dextrose in watwer, 20 mL (treatment C); Period 3: dextromethorphan syrup 30 mg (treatment B).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo (Drug)
A, C, then B
Subjects received the following: Period 1: single oral doce of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A); Period 2: placebo liquid, dextrose in watwer, 20 mL (treatment C); Period 3: dextromethorphan syrup 30 mg (treatment B).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa (Drug)
A, C, then B
Subjects received the following: Period 1: single oral doce of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A); Period 2: placebo liquid, dextrose in watwer, 20 mL (treatment C); Period 3: dextromethorphan syrup 30 mg (treatment B).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan (Drug)
A, C, then B
Subjects received the following: Period 1: single oral doce of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A); Period 2: placebo liquid, dextrose in watwer, 20 mL (treatment C); Period 3: dextromethorphan syrup 30 mg (treatment B).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.
干预措施: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa (Drug)
B, A, then C
Subjects received the following: Period 1: dextromethorphan syrup 30 mg (treatment B); Period 2: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg, in a naturally-flavored cocoa syrup (treatment A); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo (Drug)
B, A, then C
Subjects received the following: Period 1: dextromethorphan syrup 30 mg (treatment B); Period 2: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg, in a naturally-flavored cocoa syrup (treatment A); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan (Drug)
B, A, then C
Subjects received the following: Period 1: dextromethorphan syrup 30 mg (treatment B); Period 2: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg, in a naturally-flavored cocoa syrup (treatment A); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo (Drug)
B, A, then C
Subjects received the following: Period 1: dextromethorphan syrup 30 mg (treatment B); Period 2: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg, in a naturally-flavored cocoa syrup (treatment A); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa (Drug)
B, A, then C
Subjects received the following: Period 1: dextromethorphan syrup 30 mg (treatment B); Period 2: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg, in a naturally-flavored cocoa syrup (treatment A); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan (Drug)
B, A, then C
Subjects received the following: Period 1: dextromethorphan syrup 30 mg (treatment B); Period 2: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg, in a naturally-flavored cocoa syrup (treatment A); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa (Drug)
B, C, then A
Subjects received the following: Period 1: dextromethorphan 30 mg syrup (treatment B); Period 2: placebo liquid, dextrose in water, 20 mL (treatment C); Period 3: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo (Drug)
B, C, then A
Subjects received the following: Period 1: dextromethorphan 30 mg syrup (treatment B); Period 2: placebo liquid, dextrose in water, 20 mL (treatment C); Period 3: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan (Drug)
B, C, then A
Subjects received the following: Period 1: dextromethorphan 30 mg syrup (treatment B); Period 2: placebo liquid, dextrose in water, 20 mL (treatment C); Period 3: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo (Drug)
B, C, then A
Subjects received the following: Period 1: dextromethorphan 30 mg syrup (treatment B); Period 2: placebo liquid, dextrose in water, 20 mL (treatment C); Period 3: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa (Drug)
B, C, then A
Subjects received the following: Period 1: dextromethorphan 30 mg syrup (treatment B); Period 2: placebo liquid, dextrose in water, 20 mL (treatment C); Period 3: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan (Drug)
B, C, then A
Subjects received the following: Period 1: dextromethorphan 30 mg syrup (treatment B); Period 2: placebo liquid, dextrose in water, 20 mL (treatment C); Period 3: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A).
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa (Drug)
C, A, then B
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A); Period 3: dextromethorphan 30 mg syrup (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo (Drug)
C, A, then B
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A); Period 3: dextromethorphan 30 mg syrup (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa (Drug)
C, A, then B
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A); Period 3: dextromethorphan 30 mg syrup (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan (Drug)
C, A, then B
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A); Period 3: dextromethorphan 30 mg syrup (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo (Drug)
C, A, then B
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A); Period 3: dextromethorphan 30 mg syrup (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa (Drug)
C, A, then B
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A); Period 3: dextromethorphan 30 mg syrup (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan (Drug)
C, B, then A
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: dextromethorphan 30 mg syrup (treatment B); Period 3: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo (Drug)
C, B, then A
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: dextromethorphan 30 mg syrup (treatment B); Period 3: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan (Drug)
C, B, then A
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: dextromethorphan 30 mg syrup (treatment B); Period 3: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo (Drug)
C, B, then A
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: dextromethorphan 30 mg syrup (treatment B); Period 3: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa (Drug)
C, B, then A
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: dextromethorphan 30 mg syrup (treatment B); Period 3: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan (Drug)
C, B, then A
Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: dextromethorphan 30 mg syrup (treatment B); Period 3: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.
干预措施: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa (Drug)
结局指标
主要结局
Change in Cough Reflex Sensitivity to Capsaicin
时间窗: 2 hours after study drug administration
increase in C5 (decrease in cough reflex sensitivity). Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.
次要结局
未报告次要终点
研究者
Peter Dicpinigaitis
Principal Investigator
Montefiore Medical Center