Trial Outcomes & Findings for Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections (NCT NCT01062256)

Last Updated: 2013-02-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

265 participants

Primary outcome timeframe

0 to 4 hours postdose

Results posted on

2013-02-25

Participant Flow

Participants stratified by gender and time of dosing (before or at 3:00 pm versus after 3:00 pm).

Participant milestones

Participant milestones
Measure	Placebo One placebo tablet administered orally as a single dose	Buckwheat Honey 10 milliliters (mL) administered orally as a single dose	Guaifenesin One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Overall Study STARTED	55	103	107
Overall Study COMPLETED	52	96	103
Overall Study NOT COMPLETED	3	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo One placebo tablet administered orally as a single dose	Buckwheat Honey 10 milliliters (mL) administered orally as a single dose	Guaifenesin One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	1	1	1
Overall Study Ineligible	1	4	3
Overall Study Administrative	0	2	0

Baseline Characteristics

Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guaifenesin n=107 Participants One 400 milligrams (mg) immediate release tablet administered orally as a single dose	Total n=265 Participants Total of all reporting groups	Placebo n=55 Participants One placebo tablet administered orally as a single dose	Buckwheat Honey n=103 Participants 10 milliliters (mL) administered orally as a single dose
Age Continuous	32.4 years STANDARD_DEVIATION 11.1 • n=5 Participants	32.3 years STANDARD_DEVIATION 10.8 • n=4 Participants	29.9 years STANDARD_DEVIATION 9.5 • n=5 Participants	33.5 years STANDARD_DEVIATION 11.2 • n=7 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	159 Participants n=4 Participants	33 Participants n=5 Participants	62 Participants n=7 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	106 Participants n=4 Participants	22 Participants n=5 Participants	41 Participants n=7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants One placebo tablet administered orally as a single dose	Buckwheat Honey n=102 Participants 10 milliliters (mL) administered orally as a single dose	Guaifenesin n=107 Participants One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Number of Cough Bouts Over 4-hour Postdose Period	139.6 Cough bouts Standard Deviation 140.6	131.3 Cough bouts Standard Deviation 138.8	126.4 Cough bouts Standard Deviation 126.1

SECONDARY outcome

Timeframe: 0 to 2 hours postdose

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants One placebo tablet administered orally as a single dose	Buckwheat Honey n=102 Participants 10 milliliters (mL) administered orally as a single dose	Guaifenesin n=107 Participants One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Number of Cough Bouts Over 2-hour Postdose Period	83.8 cough bouts Standard Deviation 81.9	79.8 cough bouts Standard Deviation 81.8	75.0 cough bouts Standard Deviation 71.9

SECONDARY outcome

Timeframe: every 15 minutes postdose up to 240 minutes postdose

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants One placebo tablet administered orally as a single dose	Buckwheat Honey n=102 Participants 10 milliliters (mL) administered orally as a single dose	Guaifenesin n=107 Participants One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 210 minutes	6.8 cough bouts Standard Deviation 7.8	5.7 cough bouts Standard Deviation 7.6	6.3 cough bouts Standard Deviation 7.6
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 225 minutes	7.2 cough bouts Standard Deviation 8.9	5.8 cough bouts Standard Deviation 7.5	6.0 cough bouts Standard Deviation 7.6
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 240 minutes	7.1 cough bouts Standard Deviation 9.1	5.9 cough bouts Standard Deviation 8.7	6.3 cough bouts Standard Deviation 8.5
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 90 minutes	9.4 cough bouts Standard Deviation 10.3	8.7 cough bouts Standard Deviation 10.5	8.0 cough bouts Standard Deviation 9.1
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 105 minutes	9.6 cough bouts Standard Deviation 10.0	8.6 cough bouts Standard Deviation 9.9	7.9 cough bouts Standard Deviation 9.1
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 120 minutes	8.3 cough bouts Standard Deviation 7.9	8.4 cough bouts Standard Deviation 9.8	7.9 cough bouts Standard Deviation 9.3
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 135 minutes	6.8 cough bouts Standard Deviation 7.0	7.2 cough bouts Standard Deviation 9.6	6.6 cough bouts Standard Deviation 8.1
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 150 minutes	7.9 cough bouts Standard Deviation 8.6	7.1 cough bouts Standard Deviation 8.7	6.8 cough bouts Standard Deviation 7.8
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 165 minutes	7.7 cough bouts Standard Deviation 8.6	7.0 cough bouts Standard Deviation 8.3	7.0 cough bouts Standard Deviation 8.2
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 180 minutes	6.5 cough bouts Standard Deviation 7.1	6.9 cough bouts Standard Deviation 8.3	6.9 cough bouts Standard Deviation 8.0
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 195 minutes	6.1 cough bouts Standard Deviation 7.8	6.3 cough bouts Standard Deviation 8.4	5.9 cough bouts Standard Deviation 6.8
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 15 minutes	14.9 cough bouts Standard Deviation 16.8	14.5 cough bouts Standard Deviation 14.3	14.2 cough bouts Standard Deviation 12.4
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 30 minutes	12.4 cough bouts Standard Deviation 13.0	10.9 cough bouts Standard Deviation 10.9	11.0 cough bouts Standard Deviation 11.0
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 45 minutes	11.5 cough bouts Standard Deviation 11.4	10.6 cough bouts Standard Deviation 12.2	9.5 cough bouts Standard Deviation 9.5
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 60 minutes	10.1 cough bouts Standard Deviation 10.5	9.6 cough bouts Standard Deviation 10.0	8.7 cough bouts Standard Deviation 9.5
Number of Cough Bouts Within Each 15-minute Time Interval Postdose 75 minutes	8.1 cough bouts Standard Deviation 9.6	8.7 cough bouts Standard Deviation 10.0	8.2 cough bouts Standard Deviation 8.6

SECONDARY outcome

Timeframe: 1, 2, 3, and 4 hours postdose

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants One placebo tablet administered orally as a single dose	Buckwheat Honey n=102 Participants 10 milliliters (mL) administered orally as a single dose	Guaifenesin n=107 Participants One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Change From Baseline in Cough Severity Scale 1 hour postdose	0.4 units on a scale Standard Deviation 0.5	0.5 units on a scale Standard Deviation 0.6	0.3 units on a scale Standard Deviation 0.5
Change From Baseline in Cough Severity Scale 2 hours postdose	0.6 units on a scale Standard Deviation 0.6	0.7 units on a scale Standard Deviation 0.6	0.6 units on a scale Standard Deviation 0.6
Change From Baseline in Cough Severity Scale 3 hours postdose	0.8 units on a scale Standard Deviation 0.6	1.0 units on a scale Standard Deviation 0.6	0.8 units on a scale Standard Deviation 0.7
Change From Baseline in Cough Severity Scale 4 hours postdose	1.0 units on a scale Standard Deviation 0.7	1.1 units on a scale Standard Deviation 0.7	1.0 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 4 hours postdose or early termination

Population: ITT

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

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants One placebo tablet administered orally as a single dose	Buckwheat Honey n=102 Participants 10 milliliters (mL) administered orally as a single dose	Guaifenesin n=107 Participants One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Number of Participants With Global Evaluation of Study Medication Poor	5 participants	9 participants	11 participants
Number of Participants With Global Evaluation of Study Medication Fair	18 participants	28 participants	39 participants
Number of Participants With Global Evaluation of Study Medication Good	18 participants	33 participants	29 participants
Number of Participants With Global Evaluation of Study Medication Very Good	10 participants	22 participants	23 participants
Number of Participants With Global Evaluation of Study Medication Excellent	2 participants	9 participants	5 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants One placebo tablet administered orally as a single dose	Buckwheat Honey n=102 Participants 10 milliliters (mL) administered orally as a single dose	Guaifenesin n=107 Participants One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Number of Participant With Cough Severity Moderate	51 Participants	92 Participants	101 Participants
Number of Participant With Cough Severity Severe	3 Participants	10 Participants	6 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Buckwheat Honey

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Guaifenesin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=55 participants at risk One placebo tablet administered orally as a single dose	Buckwheat Honey n=103 participants at risk 10 milliliters (mL) administered orally as a single dose	Guaifenesin n=107 participants at risk One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Cardiac disorders Chest discomfort	1.8% 1/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.93% 1/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	1.8% 1/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.97% 1/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	0.00% 0/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.97% 1/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry throat	0.00% 0/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.97% 1/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Feeling jittery	1.8% 1/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.93% 1/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	3.6% 2/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.93% 1/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.00% 0/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.93% 1/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.93% 1/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/55 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.97% 1/103 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/107 The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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