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

Primary Purpose

Cough Reflex Sensitivity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo
diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan
dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo
dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa
placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan
placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough Reflex Sensitivity focused on measuring cough, cough reflex, capsaicin, diphenhydramine, phenylephrine, dextromethorphan, placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Einstein Division/Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A, B, then C

A, C, then B

B, A, then C

B, C, then A

C, A, then B

C, B, then A

Arm 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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Cough Reflex Sensitivity to Capsaicin
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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2014
Last Updated
February 26, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02062710
Brief Title
Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
Official Title
Antitussive Effect of a Naturally Flavored, Multi-Component Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough Reflex Sensitivity
Keywords
cough, cough reflex, capsaicin, diphenhydramine, phenylephrine, dextromethorphan, placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A, B, then C
Arm Type
Experimental
Arm 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.
Arm Title
A, C, then B
Arm Type
Experimental
Arm 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.
Arm Title
B, A, then C
Arm Type
Experimental
Arm 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.
Arm Title
B, C, then A
Arm Type
Experimental
Arm 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.
Arm Title
C, A, then B
Arm Type
Experimental
Arm 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.
Arm Title
C, B, then A
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo
Intervention Description
diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.
Intervention Type
Drug
Intervention Name(s)
diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan
Intervention Description
diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.
Intervention Type
Drug
Intervention Name(s)
dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo
Intervention Description
dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo
Intervention Type
Drug
Intervention Name(s)
dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa
Intervention Description
dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg
Intervention Type
Drug
Intervention Name(s)
placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan
Intervention Description
placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg
Intervention Type
Drug
Intervention Name(s)
placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa
Intervention Description
placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg
Primary Outcome Measure Information:
Title
Change in Cough Reflex Sensitivity to Capsaicin
Description
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.
Time Frame
2 hours after study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Einstein Division/Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25673148
Citation
Dicpinigaitis PV, Dhar S, Johnson A, Gayle Y, Brew J, Caparros-Wanderley W. Inhibition of cough reflex sensitivity by diphenhydramine during acute viral respiratory tract infection. Int J Clin Pharm. 2015 Jun;37(3):471-4. doi: 10.1007/s11096-015-0081-8. Epub 2015 Feb 12.
Results Reference
derived

Learn more about this trial

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

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