Phase 4 Study - Mucinex D as Adjunct Therapy

Phase 4

Completed

• Conditions: Acute Respiratory Infection; Rhinosinusitis; Bronchitis

• Registration Number: NCT00441246
• Lead Sponsor: Adams Respiratory Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-27
• Study First Posted: 2007-02-28
• Primary Completion: 2007-05
• Study Completion: 2007-07
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-05
• Last Update Posted: 2008-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (28)

Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214; 🇺🇸 Birmingham, Alabama, United States

MedCenter, 6651 Madison Ave.; 🇺🇸 Carmichael, California, United States

Torrance Clinical Research, 3640 Lomita Blfd #205; 🇺🇸 Torrance, California, United States

Clinicos, LLC; 🇺🇸 Colorado Springs, Colorado, United States

Longmont Clinic, P.C., 1925 W. Mountain View Ave.; 🇺🇸 Longmont, Colorado, United States

Front Range Clinical Research; 🇺🇸 Wheat Ridge, Colorado, United States

Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175; 🇺🇸 Dawsonville, Georgia, United States

Koch Family Medicine, 81A E. Queenwood Rd.; 🇺🇸 Morton, Illinois, United States

Welborn Clinic Gateway, 4233 Gateway Blvd; 🇺🇸 Newburgh, Indiana, United States

Sterling Research Group, Ltd., 650 Sprucewood Lane; 🇺🇸 Erlanger, Kentucky, United States

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