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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guaifenesin | Active Comparator | Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets |
|
| Placebo | Placebo Comparator | Given as 2 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucinex | Drug | Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs | Percentage of inhaled radioactive tracer (Ave180Clear) | 3 hours following inhalation of radioactive tracer particles |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Bennett, PhD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Environmental Medicine, Asthma, and Lung Biology | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26462765 | Derived | Bennett WD, Kala A, Duckworth H, Zeman KL, Wu J, Henderson A, Yopp M, Rubin BK. Effect of a single 1200 Mg dose of Mucinex(R) on mucociliary and cough clearance during an acute respiratory tract infection. Respir Med. 2015 Nov;109(11):1476-83. doi: 10.1016/j.rmed.2015.09.017. Epub 2015 Oct 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Guaifenesin | Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets |
| FG001 | Placebo | Given as 2 tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Guaifenesin | Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets |
| BG001 | Placebo | Given as 2 tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs | Percentage of inhaled radioactive tracer (Ave180Clear) | Intent to treat | Posted | Mean | Standard Deviation | Percentage of inhaled radioactive tracer | 3 hours following inhalation of radioactive tracer particles |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guaifenesin | Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail Solomon, Director, Clinical Development | Reckitt Benckiser Inc. | 973-404-2752 | gail.solomon@rb.com |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo given as 2 tablets |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Guaifenesin AUC(0-3) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 3 hours following dose administration |
|
|
|
| Secondary | Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo. | The data for this secondary outcome cannot be reported as operational issues with the collection and transport of the samples occurred. | Posted | Within 10 days of developing symptoms associated with a respiratory tract infection |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Placebo | Given as 2 tablets | 0 | 19 | 0 | 19 |
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |