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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, B, then C | Experimental | 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. |
|
| A, C, then B | Experimental | 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. |
|
| B, A, then C | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo | Drug | diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours after study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Einstein Division/Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25673148 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diphenhydramine/Phen/Cocoa, Dextromethorphan, Then Placebo | Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; then dextromethorphan 30 mg; then placebo. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Washout 1-2 days between each of the 3 dosing periods. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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.
|
| B, C, then A | Experimental | 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. |
|
| C, A, then B | Experimental | 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. |
|
| C, B, then A | Experimental | 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. |
|
| diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan | Drug | diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg. |
|
| dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo | Drug | dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo |
|
| dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa | Drug | dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg |
|
| placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan | Drug | placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg |
|
| placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa | Drug | placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg |
|
| Diphenhydramine/Phenylephrine/Cocoa, Then Placebo, Then Dextro |
diphenhydramine 25 mg and phenylephrine 10 mg; then placebo; then dextromethorphan 30 mg. Intervention: capsaicin cough challenge testing after study drug ingestion |
| FG002 | Dextromethorphan, Diphenhydramine/Phenylephrine/Cocoa, Then pl | dextromethorphan 30 mg, then diphenhydramine/phenylephrine/cocoa, then placebo. Intervention: capsaicin cough challeneg 2 hours after study drug ingestion |
| FG003 | Dextromethorphan, Placebo, Then Diphenhydramine/Phenylephrine/ | dextromethorphan 30 mg, then placebo, then diphenhydramine 25 mg and phenylephrine 10 mg. Intervention: capsaicin cough challenge 2 hours after study drug ingestion. Washout period 1-2 days between each of the 3 dosing periods |
| FG004 | Placebo, Diphenhydramine/Phenylephrine/Cocoa, Then Dextrometho | placebo, then diphenhydramine 25 mg and phenylephrine 10 mg, then dextromethorphan 30 mg. Intervention: capsaicin cough challenge 2 hours after study drug administration. Washout period 1-2 days after each of the 3 dosing periods |
| FG005 | Placebo, Dextromethorphan, Then Diphenhydramine/Phenylephrine/ | placebo, then dextromethorphan 30 mg, then diphenhydramine 25 mg and phenylephrine 10 mg. Intervention: capsaicin cough challenge 2 hours after study drug administration. Washout period 1-2 days after each of the 3 dosing periods. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diphenhydramine/Phenylephrine/Cocoa, Dextromethorphan,Placebo | Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; dextromethorphan; placebo. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Phenylephrine: 10 mg dose phenylephrine Diphenhydramine: 25 mg dose diphenhydramine Dextromethorphan: 30 mg dose dextromethorphan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | log C5 (uM) | 2 hours after study drug administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diphenhydramine/Phenylephrine/Cocoa | Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Phenylephrine: 10 mg dose phenylephrine Diphenhydramine: 25 mg dose diphenhydramine | 0 | 22 | 0 | 22 | ||
| EG001 | Dextromethorphan | Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Dextromethorphan: 30 mg dose dextromethorphan | 0 | 22 | 0 | 22 | ||
| EG002 | Placebo | placebo liquid, dextrose in water, 20 mL | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Dicpinigaitis, MD | Montefiore Medcial Center | 718-904-2676 | pdicpini@montefiore.org |
| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| D003915 | Dextromethorphan |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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