Acute Respiratory Infection
Conditions
Keywords
Acute Respiratory Infection, Mucociliary, Cough Clearance, Guaifenesin
Brief summary
The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.
Interventions
DRUGMucinex
Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study
DRUGPlacebo
Placebo given as 2 tablets
Sponsors
Reckitt Benckiser LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Symptoms of cough, thickened mucus and chest congestion * Able to produce sputum * Non Smoker
Exclusion criteria
* Pregnant * Smokers * Fever above 101°F * Any chronic illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs | 3 hours following inhalation of radioactive tracer particles | Percentage of inhaled radioactive tracer (Ave180Clear) |
Secondary
| Measure | Time frame |
|---|---|
| Guaifenesin AUC(0-3) | 3 hours following dose administration |
| Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo. | Within 10 days of developing symptoms associated with a respiratory tract infection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Guaifenesin Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets | 19 |
| Placebo Given as 2 tablets | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | Placebo | Guaifenesin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants | 38 Participants |
| Age, Continuous | 30.0 years STANDARD_DEVIATION 11.94 | 25.8 years STANDARD_DEVIATION 6 | 27.9 years STANDARD_DEVIATION 9.56 |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
Percentage of inhaled radioactive tracer (Ave180Clear)
Time frame: 3 hours following inhalation of radioactive tracer particles
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guaifenesin | Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs | 21.4 Percentage of inhaled radioactive tracer | Standard Deviation 99 |
| Placebo | Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs | 23.1 Percentage of inhaled radioactive tracer | Standard Deviation 99 |
Secondary
Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.
Time frame: 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.
Secondary
Guaifenesin AUC(0-3)
Time frame: 3 hours following dose administration
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Guaifenesin | Guaifenesin AUC(0-3) | 4060 ng*hr/mL | Geometric Coefficient of Variation 71 |