Trial Outcomes & Findings for Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo (NCT NCT02062710)
NCT ID: NCT02062710
Last Updated: 2018-02-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
2 hours after study drug administration
Results posted on
2018-02-28
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
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
|
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
|
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
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
5
|
3
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
5
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
Baseline characteristics by cohort
| Measure |
Diphenhydramine/Phenylephrine/Cocoa, Dextromethorphan,Placebo
n=22 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours after study drug administrationincrease 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.
Outcome measures
| Measure |
Diphenhydramine/Phenylephrine/Cocoa
n=22 Participants
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
|
Dextromethorphan
n=22 Participants
Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.
Dextromethorphan: 30 mg dose dextromethorphan
|
Placebo
n=22 Participants
placebo liquid, dextrose in water, 20 mL
|
|---|---|---|---|
|
Change in Cough Reflex Sensitivity to Capsaicin
|
0.97 log C5 (uM)
Standard Error 0.16
|
0.80 log C5 (uM)
Standard Error 0.18
|
0.57 log C5 (uM)
Standard Error 0.16
|
Adverse Events
Diphenhydramine/Phenylephrine/Cocoa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dextromethorphan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place