Phase 4 Study - Mucinex D as Adjunct Therapy

Acute Respiratory Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441246
• Other study ID #: 2007-MUCD-001
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2007
• Last updated: February 5, 2008
• Start date: February 2007
• Est. completion date: July 2007

Study information

• Verified date: February 2008
• Source: Adams Respiratory Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Bronchitis
• Infection
• Respiratory Tract Infections
• Rhinosinusitis

Intervention

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

Locations

Country	Name	City	State
United States	DayStar Clinical Research, Inc., 880 Mull Ave., Suite 100	Akron	Ohio
United States	Blair Medical Associates, Inc., Station Medical Center, 1414 Ninth Ave.	Altoona	Pennsylvania
United States	MetaClin Research, Inc., 6012 West William Cannon Drive, 6012 West William Cannon Drive	Austin	Texas
United States	Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214	Birmingham	Alabama
United States	Immedicenter, 557 Broad St.	Bloomfield	New Jersey
United States	Central Nebraska Medical Clinic, PC, 145 Memorial Drive	Broken Bow	Nebraska
United States	DataPharm, Inc., 6715 Tippecanoe Rd., Bldg E (LL)	Canfield	Ohio
United States	MedCenter, 6651 Madison Ave.	Carmichael	California
United States	Clinicos, LLC	Colorado Springs	Colorado
United States	Columbia Medical Practice, 3450 Knoll Dr. North #200C	Columbia	Maryland
United States	Parsons Avenue Medical Clinic, 1493 Parsons Avenue	Columbus	Ohio
United States	Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175	Dawsonville	Georgia
United States	Sterling Research Group, Ltd., 650 Sprucewood Lane	Erlanger	Kentucky
United States	Harleysville Medical Associates, 176 Main Street	Harleysville	Pennsylvania
United States	Lederach Family Medicine, PC, 658 Harleysville Pike, Suite 120	Harleysville,	Pennsylvania
United States	Michigan Institute of Medicine, 38525 Eight Mile Rd.	Livonia	Michigan
United States	Longmont Clinic, P.C., 1925 W. Mountain View Ave.	Longmont	Colorado
United States	Central New York Clinical Research, RT 92, The Market Place	Manlius	New York
United States	Milford Emergency Associates, Inc., 14 Asylum St.	Milford	Massachusetts
United States	Koch Family Medicine, 81A E. Queenwood Rd.	Morton	Illinois
United States	Welborn Clinic Gateway, 4233 Gateway Blvd	Newburgh	Indiana
United States	Greentree Medical Associates, 651 Holiday Drive, Foster Plaza Bldg #5	Pittsburgh	Pennsylvania
United States	Apollo Research Institute, 117 Dilworth Plaza	Poth	Texas
United States	North Carolina Clinical Research, 4301 Lake Boone Trail, Ste 309-A	Raleigh	North Carolina
United States	Clinical Associates, 750 Main St. #201	Reisterstown	Maryland
United States	Torrance Clinical Research, 3640 Lomita Blfd #205	Torrance	California
United States	Advanced Clinical Research, Inc., 3590 West 9000 South, Suite 230	West Jordan	Utah
United States	Front Range Clinical Research	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Adams Respiratory Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No