Trial · NCT01062256
Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections
NCT01062256, Not applicable, Completed, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2011-03-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections. Trials, record NCT01062256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01062256
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections
- NCT number
- NCT01062256
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 265 participants, actual
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Conditions
- Infection
- Interventions
- Placebo, Guaifenesin, Buckwheat Honey
- First posted
- 2010-02-04
- Last updated
- 2013-02-25
- Results first posted
- 2011-03-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Cough Bouts Over 4-hour Postdose Period | 0 to 4 hours postdose | Intent-to-Treat (ITT) Population: all randomized participants who provided baseline cough counts and were dosed with study product. | Cough bouts | MEAN |
| SECONDARY | Number of Cough Bouts Over 2-hour Postdose Period | 0 to 2 hours postdose | ITT | cough bouts | MEAN |
| SECONDARY | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | every 15 minutes postdose up to 240 minutes postdose | ITT | cough bouts | MEAN |
| SECONDARY | Change From Baseline in Cough Severity Scale | 1, 2, 3, and 4 hours postdose | ITT | units on a scale | MEAN |
| SECONDARY | Number of Participants With Global Evaluation of Study Medication | 4 hours postdose or early termination | ITT | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participant With Cough Severity | Baseline | ITT | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group87
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Cough Bouts Over 4-hour Postdose Period | Placebo | 139.6 | Standard Deviation 140.6 | Cough bouts | |
| Number of Cough Bouts Over 4-hour Postdose Period | Buckwheat Honey | 131.3 | Standard Deviation 138.8 | Cough bouts | |
| Number of Cough Bouts Over 4-hour Postdose Period | Guaifenesin | 126.4 | Standard Deviation 126.1 | Cough bouts | |
| Number of Cough Bouts Over 2-hour Postdose Period | Placebo | 83.8 | Standard Deviation 81.9 | cough bouts | |
| Number of Cough Bouts Over 2-hour Postdose Period | Buckwheat Honey | 79.8 | Standard Deviation 81.8 | cough bouts | |
| Number of Cough Bouts Over 2-hour Postdose Period | Guaifenesin | 75.0 | Standard Deviation 71.9 | cough bouts | |
| Number of Cough Bouts Within Each 15-minute Time Interval Postdose | Placebo | 15 minutes | 14.9 | Standard Deviation 16.8 | cough bouts |
| Number of Cough Bouts Within Each 15-minute Time Interval Postdose | Buckwheat Honey | 15 minutes | 14.5 | Standard Deviation 14.3 | cough bouts |
| Number of Cough Bouts Within Each 15-minute Time Interval Postdose | Guaifenesin | 15 minutes | 14.2 | Standard Deviation 12.4 | cough bouts |
| Number of Cough Bouts Within Each 15-minute Time Interval Postdose | Placebo | 30 minutes | 12.4 | Standard Deviation 13.0 | cough bouts |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | STARTED | Buckwheat Honey | 103 | |
| Overall Study | STARTED | Guaifenesin | 107 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | COMPLETED | Buckwheat Honey | 96 | |
| Overall Study | COMPLETED | Guaifenesin | 103 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Buckwheat Honey | 7 | |
| Overall Study | NOT COMPLETED | Guaifenesin | 4 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chest discomfort | Cardiac disorders | Placebo | 1 | 55 | |
| other | Chest discomfort | Cardiac disorders | Buckwheat Honey | 0 | 103 | |
| other | Chest discomfort | Cardiac disorders | Guaifenesin | 1 | 107 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 55 | |
| other | Nausea | Gastrointestinal disorders | Buckwheat Honey | 1 | 103 | |
| other | Nausea | Gastrointestinal disorders | Guaifenesin | 0 | 107 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 55 | |
| other | Dry mouth | Gastrointestinal disorders | Buckwheat Honey | 1 | 103 | |
| other | Dry mouth | Gastrointestinal disorders | Guaifenesin | 0 | 107 | |
| other | Dry throat | Gastrointestinal disorders | Placebo | 0 | 55 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Buckwheat Honey | ||
| Total, all-cause mortality | Guaifenesin | ||
| Total, other adverse events | Placebo | 3 | 55 |
| Total, other adverse events | Buckwheat Honey | 3 | 103 |
| Total, other adverse events | Guaifenesin | 4 | 107 |
| Total, serious adverse events | Placebo | 0 | 55 |
| Total, serious adverse events | Buckwheat Honey | 0 | 103 |
| Total, serious adverse events | Guaifenesin | 0 | 107 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01062256
GET https://conductscience.org/api/trials/v1/NCT01062256/results?page=2