Acute Respiratory Infection, Bronchitis, Rhinosinusitis
Conditions
Keywords
Acute Respiratory Infection, Bronchitis, Rhinosinusitis
Brief summary
The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
Interventions
DRUGMucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)
Sponsors
Adams Respiratory Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ages Eligible for Study: 18 to 75 years, * Genders Eligible for Study: Both * Adult patients presenting at the physician's office with symptoms diagnostic for acute respiratory infection, such as bronchitis or rhinosinusitis; with a clinical diagnosis of acute respiratory infection, meeting the physician's usual diagnostic criteria in practice for prescription of oral antibiotics. * The investigator will evaluate patients on a total of seven criteria for inclusion.
Exclusion criteria
* Have chronic, recurring respiratory signs and symptoms, such as allergic rhinitis or chronic bronchitis, which, in the investigator's opinion, would confound interpretation of symptoms ratings for the acute respiratory infection; * The Investigator will evaluate patients on twelve additional criteria for exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection. | 7 days |
Countries
United States
Outcome results
None listed