Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Cough Reflex Sensitivity

Treatments: Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo; Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan; Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa; Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan; Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo; Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Study type: Interventional

Funder types: Other

Identifiers

NCT02062710

MMC-IRB-13-10-170

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• healthy adult nonsmokers
• onset of acute, viral upper respiratory tract infection (common cold) within 72 hours of enrollment

Exclusion criteria

• smokers
• history of asthma or other respiratory disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 6 patient groups

A, B, then C

Experimental group

Description:

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.

Treatment:

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

A, C, then B

Experimental group

Description:

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.

Treatment:

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

B, A, then C

Experimental group

Description:

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.

Treatment:

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

B, C, then A

Experimental group

Description:

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.

Treatment:

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

C, A, then B

Experimental group

Description:

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.

Treatment:

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

C, B, then A

Experimental group

Description:

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.

Treatment:

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo