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Cough Reflex Sensitivity | Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo

Cough Reflex Sensitivity research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cough Reflex Sensitivity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebodiphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.

Drug:diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphandiphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.

Drug:dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebodextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo

Drug:dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoadextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg

Drug:placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphanplacebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg

Drug:placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoaplacebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

A, B, then CSubjects 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.

A, C, then BSubjects 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.

B, A, then CSubjects 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.

B, C, then ASubjects 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.

C, A, then BSubjects 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.

C, B, then ASubjects 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.

Study Status

Completed

Start Date: January 2014

Completed Date: June 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change in Cough Reflex Sensitivity to Capsaicin

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Montefiore Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02062710

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