Phase 4 Study - Mucinex D as Adjunct Therapy

Condition(s) targeted: Acute Respiratory Infection; Bronchitis; Rhinosinusitis

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

Phase: Phase 4

Status: Completed

Sponsored by: Adams Respiratory Therapeutics

Official(s) and/or principal investigator(s):
Helmut Albrecht, M.D., Study Chair, Affiliation: Adams Respiratory Therapeutics

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.

Official title: A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Mucinex D as Adjunct Therapy to Antibiotic Treatment of Acute Respiratory Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214, Birmingham, Alabama 35235, United States

MedCenter, 6651 Madison Ave., Carmichael, California 95608, United States

Torrance Clinical Research, 3640 Lomita Blfd #205, Torrance, California 90505, United States

Clinicos, LLC, Colorado Springs, Colorado 80904, United States

Longmont Clinic, P.C., 1925 W. Mountain View Ave., Longmont, Colorado 80501, United States

Front Range Clinical Research, Wheat Ridge, Colorado 80033, United States

Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175, Dawsonville, Georgia 30534, United States

Koch Family Medicine, 81A E. Queenwood Rd., Morton, Illinois 61550, United States

Welborn Clinic Gateway, 4233 Gateway Blvd, Newburgh, Indiana 47630, United States

Sterling Research Group, Ltd., 650 Sprucewood Lane, Erlanger, Kentucky 41018, United States

Columbia Medical Practice, 3450 Knoll Dr. North #200C, Columbia, Maryland 21045, United States

Clinical Associates, 750 Main St. #201, Reisterstown, Maryland 21136, United States

Milford Emergency Associates, Inc., 14 Asylum St., Milford, Massachusetts 01757, United States

Michigan Institute of Medicine, 38525 Eight Mile Rd., Livonia, Michigan 48152, United States

Central Nebraska Medical Clinic, PC, 145 Memorial Drive, Broken Bow, Nebraska 68822, United States

Immedicenter, 557 Broad St., Bloomfield, New Jersey 07003, United States

Central New York Clinical Research, RT 92, The Market Place, Manlius, New York 13104, United States

North Carolina Clinical Research, 4301 Lake Boone Trail, Ste 309-A, Raleigh, North Carolina 27607, United States

DayStar Clinical Research, Inc., 880 Mull Ave., Suite 100, Akron, Ohio 44313, United States

DataPharm, Inc., 6715 Tippecanoe Rd., Bldg E (LL), Canfield, Ohio 44406, United States

Parsons Avenue Medical Clinic, 1493 Parsons Avenue, Columbus, Ohio 43207, United States

Blair Medical Associates, Inc., Station Medical Center, 1414 Ninth Ave., Altoona, Pennsylvania 16602, United States

Lederach Family Medicine, PC, 658 Harleysville Pike, Suite 120, Harleysville,, Pennsylvania 19438, United States

Harleysville Medical Associates, 176 Main Street, Harleysville, Pennsylvania 19438, United States

Greentree Medical Associates, 651 Holiday Drive, Foster Plaza Bldg #5, Pittsburgh, Pennsylvania 15220, United States

MetaClin Research, Inc., 6012 West William Cannon Drive, 6012 West William Cannon Drive, Austin, Texas 78749, United States

Apollo Research Institute, 117 Dilworth Plaza, Poth, Texas 78114, United States

Advanced Clinical Research, Inc., 3590 West 9000 South, Suite 230, West Jordan, Utah 84088, United States

Starting date: February 2007
Last updated: February 5, 2008