Infection
Conditions
Keywords
Cough assessment in upper respiratory infection, guaifenesin, honey
Brief summary
The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.
Interventions
DRUGPlacebo
One placebo tablet administered orally as a single dose
DRUGGuaifenesin
One 400 mg immediate release tablet administered orally as a single dose
OTHERBuckwheat Honey
10 mL administered orally as a single dose
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects at least 18 years of age and in generally good health who are experiencing an acute upper respiratory infection of 10 days or less in duration; * Subjects currently have acute cough self-rated as at least moderate due to an acute Upper Respiratory Infection (URTI) (i.e., cold or flu) as established by a study physician, nurse practitioner, or physician's assistant; * Subjects who have \> 5 cough bouts during the 30 minute baseline assessment period
Exclusion criteria
* Subjects who have acute, subchronic, or chronic cough due to any condition other than a URTI as established by the Investigator, nurse practitioner, or physician's assistant, in accordance with the American College of Chest Physicians (ACCP) Guidelines for Diagnosis and Management of Cough. Special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, Chronic Obstructive Pulmonary Disease (COPD), and Gastroesophageal Reflux Disease (GERD) (N.B. Subjects with exercise-induced asthma may be eligible for the study as long as they have not experienced an episode of asthma within 24 hours of enrollment) * In the opinion of a study physician, nurse practitioner, or physician's assistant, subjects with sinusitis or who have a history of (within the past 2 years) frequent clinically significant sinusitis; * Subjects with a history (within the last 3 years) of alcohol abuse (i.e., consuming greater than or equal to 3 alcoholic drinks/day on a regular basis) or substance abuse (i.e., ingesting/smoking marijuana more than once a week at any time during the past 6 months or using any other recreational drug more than once during the past 6 months). (Note: One drink of alcohol=1 oz. liquor, 6 oz wine, 12 oz. beer.);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cough Bouts Over 4-hour Postdose Period | 0 to 4 hours postdose | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cough Bouts Over 2-hour Postdose Period | 0 to 2 hours postdose | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts. |
| Number of Cough Bouts Within Each 15-minute Time Interval Postdose | every 15 minutes postdose up to 240 minutes postdose | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals. |
| Change From Baseline in Cough Severity Scale | 1, 2, 3, and 4 hours postdose | Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement. |
| Number of Participants With Global Evaluation of Study Medication | 4 hours postdose or early termination | Participant-rated evaluation of study product; Participants responded to the following question: How would you rate this product as a cough reliever? 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant With Cough Severity | Baseline | Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate. |
Countries
United States
Participant flow
Pre-assignment details
Participants stratified by gender and time of dosing (before or at 3:00 pm versus after 3:00 pm).
Participants by arm
| Arm | Count |
|---|---|
| Placebo One placebo tablet administered orally as a single dose | 55 |
| Buckwheat Honey 10 milliliters (mL) administered orally as a single dose | 103 |
| Guaifenesin One 400 milligrams (mg) immediate release tablet administered orally as a single dose | 107 |
| Total | 265 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative | 0 | 2 | 0 |
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Ineligible | 1 | 4 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Buckwheat Honey | Guaifenesin | Total |
|---|---|---|---|---|
| Age Continuous | 29.9 years STANDARD_DEVIATION 9.5 | 33.5 years STANDARD_DEVIATION 11.2 | 32.4 years STANDARD_DEVIATION 11.1 | 32.3 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 33 Participants | 62 Participants | 64 Participants | 159 Participants |
| Sex: Female, Male Male | 22 Participants | 41 Participants | 43 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 55 | 3 / 103 | 4 / 107 |
| serious Total, serious adverse events | 0 / 55 | 0 / 103 | 0 / 107 |
Outcome results
Primary
Number of Cough Bouts Over 4-hour Postdose Period
Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.
Time frame: 0 to 4 hours postdose
Population: Intent-to-Treat (ITT) Population: all randomized participants who provided baseline cough counts and were dosed with study product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cough Bouts Over 4-hour Postdose Period | 139.6 Cough bouts | Standard Deviation 140.6 |
| Buckwheat Honey | Number of Cough Bouts Over 4-hour Postdose Period | 131.3 Cough bouts | Standard Deviation 138.8 |
| Guaifenesin | Number of Cough Bouts Over 4-hour Postdose Period | 126.4 Cough bouts | Standard Deviation 126.1 |
Comparison: Pairwise comparison of number of cough bouts over 4-hour postdose period.p-value: 0.21695% CI: [0.64, 1.1]Poisson regression model
Comparison: Pairwise comparison of number of cough bouts over 4-hour postdose period.p-value: 0.51395% CI: [0.72, 1.18]Poisson regression model
Comparison: Pairwise comparison of number of cough bouts over 4-hour postdose period.p-value: 0.45995% CI: [0.87, 1.38]Poisson regression model
Secondary
Change From Baseline in Cough Severity Scale
Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement.
Time frame: 1, 2, 3, and 4 hours postdose
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Cough Severity Scale | 1 hour postdose | 0.4 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Cough Severity Scale | 2 hours postdose | 0.6 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Cough Severity Scale | 3 hours postdose | 0.8 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Cough Severity Scale | 4 hours postdose | 1.0 units on a scale | Standard Deviation 0.7 |
| Buckwheat Honey | Change From Baseline in Cough Severity Scale | 4 hours postdose | 1.1 units on a scale | Standard Deviation 0.7 |
| Buckwheat Honey | Change From Baseline in Cough Severity Scale | 1 hour postdose | 0.5 units on a scale | Standard Deviation 0.6 |
| Buckwheat Honey | Change From Baseline in Cough Severity Scale | 3 hours postdose | 1.0 units on a scale | Standard Deviation 0.6 |
| Buckwheat Honey | Change From Baseline in Cough Severity Scale | 2 hours postdose | 0.7 units on a scale | Standard Deviation 0.6 |
| Guaifenesin | Change From Baseline in Cough Severity Scale | 4 hours postdose | 1.0 units on a scale | Standard Deviation 0.7 |
| Guaifenesin | Change From Baseline in Cough Severity Scale | 2 hours postdose | 0.6 units on a scale | Standard Deviation 0.6 |
| Guaifenesin | Change From Baseline in Cough Severity Scale | 3 hours postdose | 0.8 units on a scale | Standard Deviation 0.7 |
| Guaifenesin | Change From Baseline in Cough Severity Scale | 1 hour postdose | 0.3 units on a scale | Standard Deviation 0.5 |
Comparison: Pairwise comparison of change from baseline in cough severity at 1 hour postdosep-value: 0.26495% CI: [-0.08, 0.27]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 1 hour postdosep-value: 0.73795% CI: [-0.2, 0.14]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 1 hour postdosep-value: 0.07895% CI: [-0.27, 0.01]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 2 hour postdosep-value: 0.12595% CI: [-0.04, 0.36]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 2 hour postdosep-value: 0.68895% CI: [-0.16, 0.24]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 2 hour postdosep-value: 0.16695% CI: [-0.29, 0.05]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 3 hour postdosep-value: 0.23395% CI: [-0.09, 0.35]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 3 hour postdosep-value: 0.84895% CI: [-0.24, 0.19]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 3 hour postdosep-value: 0.09395% CI: [-0.33, 0.03]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 4 hour postdosep-value: 0.40695% CI: [-0.14, 0.34]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 4 hour postdosep-value: 0.99195% CI: [-0.24, 0.24]ANOVA
Comparison: Pairwise comparison of change from baseline in cough severity at 4 hour postdosep-value: 0.30695% CI: [-0.3, 0.09]ANOVA
Secondary
Number of Cough Bouts Over 2-hour Postdose Period
Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.
Time frame: 0 to 2 hours postdose
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Cough Bouts Over 2-hour Postdose Period | 83.8 cough bouts | Standard Deviation 81.9 |
| Buckwheat Honey | Number of Cough Bouts Over 2-hour Postdose Period | 79.8 cough bouts | Standard Deviation 81.8 |
| Guaifenesin | Number of Cough Bouts Over 2-hour Postdose Period | 75.0 cough bouts | Standard Deviation 71.9 |
Comparison: Pairwise comparison of number of cough bouts over 2-hour postdose period.p-value: 0.19595% CI: [0.65, 1.09]Poisson regression model
Comparison: Pairwise comparison of number of cough bouts over 2-hour postdose period.p-value: 0.43895% CI: [0.71, 1.16]Poisson regression model
Comparison: Pairwise comparison of number of cough bouts over 2-hour postdose period.p-value: 0.49795% CI: [0.87, 1.34]Poisson regression model
Secondary
Number of Cough Bouts Within Each 15-minute Time Interval Postdose
Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals.
Time frame: every 15 minutes postdose up to 240 minutes postdose
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 75 minutes | 8.1 cough bouts | Standard Deviation 9.6 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 30 minutes | 12.4 cough bouts | Standard Deviation 13 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 45 minutes | 11.5 cough bouts | Standard Deviation 11.4 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 60 minutes | 10.1 cough bouts | Standard Deviation 10.5 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 15 minutes | 14.9 cough bouts | Standard Deviation 16.8 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 90 minutes | 9.4 cough bouts | Standard Deviation 10.3 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 105 minutes | 9.6 cough bouts | Standard Deviation 10 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 120 minutes | 8.3 cough bouts | Standard Deviation 7.9 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 135 minutes | 6.8 cough bouts | Standard Deviation 7 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 150 minutes | 7.9 cough bouts | Standard Deviation 8.6 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 165 minutes | 7.7 cough bouts | Standard Deviation 8.6 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 180 minutes | 6.5 cough bouts | Standard Deviation 7.1 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 195 minutes | 6.1 cough bouts | Standard Deviation 7.8 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 210 minutes | 6.8 cough bouts | Standard Deviation 7.8 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 225 minutes | 7.2 cough bouts | Standard Deviation 8.9 |
| Placebo | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 240 minutes | 7.1 cough bouts | Standard Deviation 9.1 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 90 minutes | 8.7 cough bouts | Standard Deviation 10.5 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 105 minutes | 8.6 cough bouts | Standard Deviation 9.9 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 120 minutes | 8.4 cough bouts | Standard Deviation 9.8 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 210 minutes | 5.7 cough bouts | Standard Deviation 7.6 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 135 minutes | 7.2 cough bouts | Standard Deviation 9.6 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 150 minutes | 7.1 cough bouts | Standard Deviation 8.7 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 240 minutes | 5.9 cough bouts | Standard Deviation 8.7 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 165 minutes | 7.0 cough bouts | Standard Deviation 8.3 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 15 minutes | 14.5 cough bouts | Standard Deviation 14.3 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 225 minutes | 5.8 cough bouts | Standard Deviation 7.5 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 30 minutes | 10.9 cough bouts | Standard Deviation 10.9 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 180 minutes | 6.9 cough bouts | Standard Deviation 8.3 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 45 minutes | 10.6 cough bouts | Standard Deviation 12.2 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 60 minutes | 9.6 cough bouts | Standard Deviation 10 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 75 minutes | 8.7 cough bouts | Standard Deviation 10 |
| Buckwheat Honey | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 195 minutes | 6.3 cough bouts | Standard Deviation 8.4 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 165 minutes | 7.0 cough bouts | Standard Deviation 8.2 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 90 minutes | 8.0 cough bouts | Standard Deviation 9.1 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 195 minutes | 5.9 cough bouts | Standard Deviation 6.8 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 45 minutes | 9.5 cough bouts | Standard Deviation 9.5 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 105 minutes | 7.9 cough bouts | Standard Deviation 9.1 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 240 minutes | 6.3 cough bouts | Standard Deviation 8.5 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 15 minutes | 14.2 cough bouts | Standard Deviation 12.4 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 120 minutes | 7.9 cough bouts | Standard Deviation 9.3 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 180 minutes | 6.9 cough bouts | Standard Deviation 8 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 75 minutes | 8.2 cough bouts | Standard Deviation 8.6 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 135 minutes | 6.6 cough bouts | Standard Deviation 8.1 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 210 minutes | 6.3 cough bouts | Standard Deviation 7.6 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 30 minutes | 11.0 cough bouts | Standard Deviation 11 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 150 minutes | 6.8 cough bouts | Standard Deviation 7.8 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 60 minutes | 8.7 cough bouts | Standard Deviation 9.5 |
| Guaifenesin | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | 225 minutes | 6.0 cough bouts | Standard Deviation 7.6 |
Comparison: Pairwise comparison of the number of cough bouts within 15 minutes postdosep-value: 0.2595% CI: [0.64, 1.12]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts within 15 minutes postdosep-value: 0.80295% CI: [0.75, 1.25]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts within 15 minutes postdosep-value: 0.18895% CI: [0.94, 1.39]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdosep-value: 0.09195% CI: [0.58, 1.04]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdosep-value: 0.46595% CI: [0.69, 1.19]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdosep-value: 0.20795% CI: [0.92, 1.46]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdosep-value: 0.12295% CI: [0.62, 1.06]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdosep-value: 0.16595% CI: [0.66, 1.07]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdosep-value: 0.71195% CI: [0.83, 1.32]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdosep-value: 0.21595% CI: [0.64, 1.11]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdosep-value: 0.36795% CI: [0.67, 1.16]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdosep-value: 0.68795% CI: [0.82, 1.35]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdosep-value: 0.7395% CI: [0.67, 1.32]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdosep-value: 0.92395% CI: [0.74, 1.39]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdosep-value: 0.57395% CI: [0.83, 1.4]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdosep-value: 0.28995% CI: [0.61, 1.16]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdosep-value: 0.37995% CI: [0.64, 1.18]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdosep-value: 0.78595% CI: [0.79, 1.37]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdosep-value: 0.19495% CI: [0.6, 1.11]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdosep-value: 0.21295% CI: [0.62, 1.11]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdosep-value: 0.90195% CI: [0.77, 1.34]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdosep-value: 0.695% CI: [0.7, 1.23]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdosep-value: 0.85395% CI: [0.74, 1.29]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdosep-value: 0.73695% CI: [0.79, 1.39]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdosep-value: 0.74495% CI: [0.7, 1.3]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdosep-value: 0.90495% CI: [0.72, 1.33]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdosep-value: 0.82895% CI: [0.77, 1.39]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdosep-value: 0.14795% CI: [0.59, 1.08]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdosep-value: 0.34595% CI: [0.65, 1.16]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdosep-value: 0.53295% CI: [0.83, 1.44]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdosep-value: 0.26195% CI: [0.61, 1.15]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdosep-value: 0.60195% CI: [0.69, 1.24]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdosep-value: 0.4795% CI: [0.84, 1.47]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdosep-value: 0.83495% CI: [0.71, 1.32]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdosep-value: 0.62895% CI: [0.81, 1.43]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdosep-value: 0.48195% CI: [0.83, 1.48]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdosep-value: 0.74995% CI: [0.65, 1.37]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdosep-value: 0.85795% CI: [0.7, 1.35]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdosep-value: 0.84795% CI: [0.76, 1.41]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdosep-value: 0.14695% CI: [0.54, 1.09]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdosep-value: 0.70295% CI: [0.69, 1.29]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdosep-value: 0.22895% CI: [0.88, 1.69]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdosep-value: 0.1395% CI: [0.51, 1.09]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdosep-value: 0.37195% CI: [0.6, 1.21]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdosep-value: 0.4395% CI: [0.82, 1.58]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdosep-value: 0.17795% CI: [0.51, 1.13]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdosep-value: 0.5895% CI: [0.64, 1.28]Poisson regression model
Comparison: Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdosep-value: 0.33395% CI: [0.84, 1.7]Poisson regression model
Secondary
Number of Participants With Global Evaluation of Study Medication
Participant-rated evaluation of study product; Participants responded to the following question: How would you rate this product as a cough reliever? 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent
Time frame: 4 hours postdose or early termination
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Global Evaluation of Study Medication | Very Good | 10 participants |
| Placebo | Number of Participants With Global Evaluation of Study Medication | Good | 18 participants |
| Placebo | Number of Participants With Global Evaluation of Study Medication | Poor | 5 participants |
| Placebo | Number of Participants With Global Evaluation of Study Medication | Fair | 18 participants |
| Placebo | Number of Participants With Global Evaluation of Study Medication | Excellent | 2 participants |
| Buckwheat Honey | Number of Participants With Global Evaluation of Study Medication | Good | 33 participants |
| Buckwheat Honey | Number of Participants With Global Evaluation of Study Medication | Poor | 9 participants |
| Buckwheat Honey | Number of Participants With Global Evaluation of Study Medication | Fair | 28 participants |
| Buckwheat Honey | Number of Participants With Global Evaluation of Study Medication | Very Good | 22 participants |
| Buckwheat Honey | Number of Participants With Global Evaluation of Study Medication | Excellent | 9 participants |
| Guaifenesin | Number of Participants With Global Evaluation of Study Medication | Excellent | 5 participants |
| Guaifenesin | Number of Participants With Global Evaluation of Study Medication | Very Good | 23 participants |
| Guaifenesin | Number of Participants With Global Evaluation of Study Medication | Poor | 11 participants |
| Guaifenesin | Number of Participants With Global Evaluation of Study Medication | Good | 29 participants |
| Guaifenesin | Number of Participants With Global Evaluation of Study Medication | Fair | 39 participants |
Comparison: Pairwise comparison of global evaluation of study medication.p-value: 0.25495% CI: [-0.09, 0.39]Cochran-Mantel-Haenszel
Comparison: Pairwise comparison of global evaluation of study medication.p-value: 0.94995% CI: [-0.25, 0.23]Cochran-Mantel-Haenszel
Comparison: Pairwise comparison of global evaluation of study medication.p-value: 0.25695% CI: [-0.32, 0.08]Cochran-Mantel-Haenszel
Other Pre-specified
Number of Participant With Cough Severity
Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate.
Time frame: Baseline
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participant With Cough Severity | Moderate | 51 Participants |
| Placebo | Number of Participant With Cough Severity | Severe | 3 Participants |
| Buckwheat Honey | Number of Participant With Cough Severity | Moderate | 92 Participants |
| Buckwheat Honey | Number of Participant With Cough Severity | Severe | 10 Participants |
| Guaifenesin | Number of Participant With Cough Severity | Moderate | 101 Participants |
| Guaifenesin | Number of Participant With Cough Severity | Severe | 6 Participants |