Acute Upper Respiratory Track Infection
Conditions
Keywords
Acute Upper Respiratory Track Infection Who Seek Treatment
Brief summary
The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo
Interventions
DRUGGuaifenesin
1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days
DEVICEPlacebo
Placebo bid for 7 days
Sponsors
Reckitt Benckiser Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients aged 18 to 75 yrs of age presenting at a clinical site with symptoms diagnostic for an acute upper respiratory tract infection within the last 5 days
Exclusion criteria
* patients who had chronic, recurring respiratory signs and symptoms due to conditions such as chronic allergic rhinitis, chronic sinusitis or chronic bronchitis which in the investigator's opinion, confounded interpretation of symptom ratings for the acute upper respiratory infection. Also excluded were patients with a fever greater than 101 degrees F.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic Sparing | Day 7 | Number of patients who received an antibiotic |
| Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21). | Baseline and 7 Days | WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place October 2009 through April 2010. Advertising was not allowed for this study. Patients were seen by a Health Care Provider(HCP) and must have been seeking treatment for symptoms diagnostic for an acute upper respiratory tract infection.
Participants by arm
| Arm | Count |
|---|---|
| Mucinex D Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days | 591 |
| Placebo Placebo given bid with a full glass of water for 7 days | 588 |
| Total | 1,179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 6 |
| Overall Study | Lost to Follow-up | 10 | 7 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | study compliance | 5 | 2 |
| Overall Study | Withdrawal by Subject | 13 | 10 |
Baseline characteristics
| Characteristic | Placebo | Mucinex D | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 16 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 575 Participants | 575 Participants | 1150 Participants |
| Age, Continuous | 38.8 years STANDARD_DEVIATION 13.7 | 37.4 years STANDARD_DEVIATION 13.7 | 38.1 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment United States | 588 participants | 591 participants | 1179 participants |
| Sex: Female, Male Female | 404 Participants | 395 Participants | 799 Participants |
| Sex: Female, Male Male | 184 Participants | 196 Participants | 380 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 593 | 21 / 591 |
| serious Total, serious adverse events | 0 / 593 | 0 / 591 |
Outcome results
Primary
Antibiotic Sparing
Number of patients who received an antibiotic
Time frame: Day 7
Population: Per Protocol Population using Fishers Exact Test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mucinex D | Antibiotic Sparing | 89 Participants |
| Placebo | Antibiotic Sparing | 121 Participants |
p-value: 0.025Fisher Exact
Primary
Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.
Time frame: Baseline and 7 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mucinex D | Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21). | -14.2 units on a scale | Standard Deviation 7.71 |
| Placebo | Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21). | -13.4 units on a scale | Standard Deviation 7.99 |
p-value: 0.022ANCOVA