Phase 4 Study - Mucinex D as Adjunct Therapy

Adams Respiratory Therapeutics

Status and phase

Completed

Phase 4

Conditions

Acute Respiratory Infection

Rhinosinusitis

Bronchitis

Treatments

Drug: Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00441246

2007-MUCD-001

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.