Common Cold
Conditions
Keywords
common cold
Brief summary
This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.
Interventions
DRUGguaifenesin (Mucinex)
bid 7 days
DRUGplacebo
bid 7 days
Sponsors
Reckitt Benckiser Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* common cold symptoms * meet symptom severity * females of child-bearing potential must have negative pregnancy test and use effective birth control
Exclusion criteria
* chronic respiratory conditions * significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder * pregnant or lactating * known malignancy * participation in any other clinical trial within 30 days of baseline * related to another enrolled patient or persons involved directly or indirectly with the conduct of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's End of Study Assessment of Treatment | 7 days | Yes the investigator would use this treatment for cold symptoms in the future. |
| Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough. | Baseline and Day 4 | Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events | 7 days | Total number of patients with adverse events that were possibly or probably related. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from waiting rooms of health care providers/clinics between December 2009 and March 2010.
Pre-assignment details
Participants screened over 2 day period who suffer from an acute respiratory tract infection.
Participants by arm
| Arm | Count |
|---|---|
| Mucinex 2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS | 188 |
| Placebo 2 TABLETS EVERY 12 HOURS FOR 7 DAYS | 190 |
| Total | 378 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Placebo | Mucinex | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 1 Participants | 6 Participants |
| Age, Categorical >=65 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 175 Participants | 178 Participants | 353 Participants |
| Age, Continuous | 40.8 years STANDARD_DEVIATION 15.04 | 41.1 years STANDARD_DEVIATION 13.91 | 41.0 years STANDARD_DEVIATION 14.47 |
| Region of Enrollment United States | 190 participants | 188 participants | 378 participants |
| Sex: Female, Male Female | 84 Participants | 96 Participants | 180 Participants |
| Sex: Female, Male Male | 106 Participants | 92 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 188 | 0 / 189 |
| serious Total, serious adverse events | 1 / 188 | 0 / 189 |
Outcome results
Primary
Investigator's End of Study Assessment of Treatment
Yes the investigator would use this treatment for cold symptoms in the future.
Time frame: 7 days
Population: MITT defined as all participants receiving at least 1 dose of study medication and had 1 or more efficacy assessment after Baseline. Last observation carried forward method was applied to missing post baseline measurement in the analyses of the MITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mucinex | Investigator's End of Study Assessment of Treatment | 163 participants |
| Placebo | Investigator's End of Study Assessment of Treatment | 149 participants |
Comparison: Investigator's End-of-Study Assessment NOTE: All assessments of efficacy were considered exploratory and were given equal consideration, and were carried out on both the MITT and PP populations. LOCF method was applied to missing post baseline measurements in analyses of the MITT population.p-value: 0.0096Regression, Logistic
Primary
Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.
Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.
Time frame: Baseline and Day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mucinex | Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough. | -1.1 units on a scale | Standard Deviation 0.14 |
| Placebo | Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough. | -0.9 units on a scale | Standard Deviation 0.14 |
p-value: 0.0293Wilcoxon (Mann-Whitney)
Secondary
Number of Patients With Adverse Events
Total number of patients with adverse events that were possibly or probably related.
Time frame: 7 days
Population: All participants who received study medication, excluding participants who later returned all the dispensed study medication to the site unused.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mucinex | Number of Patients With Adverse Events | 12 participants |
| Placebo | Number of Patients With Adverse Events | 6 participants |