Trial Outcomes & Findings for Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection (NCT NCT01114581)

Results Overview

Percentage of inhaled radioactive tracer (Ave180Clear)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

3 hours following inhalation of radioactive tracer particles

Results posted on

2018-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Guaifenesin Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets	Placebo Given as 2 tablets
Overall Study STARTED	19	19
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guaifenesin n=19 Participants Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets	Placebo n=19 Participants Given as 2 tablets	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25.8 years STANDARD_DEVIATION 6.0 • n=5 Participants	30.0 years STANDARD_DEVIATION 11.94 • n=7 Participants	27.9 years STANDARD_DEVIATION 9.56 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 hours following inhalation of radioactive tracer particles

Population: Intent to treat

Percentage of inhaled radioactive tracer (Ave180Clear)

Outcome measures

Outcome measures
Measure	Guaifenesin n=19 Participants Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets	Placebo n=19 Participants Given as 2 tablets
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs	21.4 Percentage of inhaled radioactive tracer Standard Deviation 99	23.1 Percentage of inhaled radioactive tracer Standard Deviation 99

SECONDARY outcome

Timeframe: 3 hours following dose administration

Outcome measures

Outcome measures
Measure	Guaifenesin n=19 Participants Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets	Placebo Given as 2 tablets
Guaifenesin AUC(0-3)	4060 ng*hr/mL Geometric Coefficient of Variation 71	—

SECONDARY outcome

Timeframe: Within 10 days of developing symptoms associated with a respiratory tract infection

Population: The data for this secondary outcome cannot be reported as operational issues with the collection and transport of the samples occurred.

Outcome measures

Outcome data not reported

Adverse Events

Guaifenesin

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

Gail Solomon, Director, Clinical Development

Reckitt Benckiser Inc.

Phone: 973-404-2752

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60