Clinical trial NCT00441246: Phase 4 Study - Mucinex D as Adjunct Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Respiratory Infection
Bronchitis
Rhinosinusitis
Keywords: Acute Respiratory Infection
Bronchitis
Rhinosinusitis
Lead sponsor: Adams Respiratory Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-02-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214
state: Alabama
city: Carmichael
country: United States
facility: MedCenter, 6651 Madison Ave.
state: California
city: Torrance
country: United States
facility: Torrance Clinical Research, 3640 Lomita Blfd #205
state: California
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Longmont
country: United States
facility: Longmont Clinic, P.C., 1925 W. Mountain View Ave.
state: Colorado
city: Wheat Ridge
country: United States
facility: Front Range Clinical Research
state: Colorado
city: Dawsonville
country: United States
facility: Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175
state: Georgia
city: Morton
country: United States
facility: Koch Family Medicine, 81A E. Queenwood Rd.
state: Illinois
city: Newburgh
country: United States
facility: Welborn Clinic Gateway, 4233 Gateway Blvd
state: Indiana
city: Erlanger
country: United States
facility: Sterling Research Group, Ltd., 650 Sprucewood Lane
state: Kentucky
city: Columbia
country: United States
facility: Columbia Medical Practice, 3450 Knoll Dr. North #200C
state: Maryland
city: Reisterstown
country: United States
facility: Clinical Associates, 750 Main St. #201
state: Maryland
city: Milford
country: United States
facility: Milford Emergency Associates, Inc., 14 Asylum St.
state: Massachusetts
city: Livonia
country: United States
facility: Michigan Institute of Medicine, 38525 Eight Mile Rd.
state: Michigan
city: Broken Bow
country: United States
facility: Central Nebraska Medical Clinic, PC, 145 Memorial Drive
state: Nebraska
city: Bloomfield
country: United States
facility: Immedicenter, 557 Broad St.
state: New Jersey
city: Manlius
country: United States
facility: Central New York Clinical Research, RT 92, The Market Place
state: New York
city: Raleigh
country: United States
facility: North Carolina Clinical Research, 4301 Lake Boone Trail, Ste 309-A
state: North Carolina
city: Akron
country: United States
facility: DayStar Clinical Research, Inc., 880 Mull Ave., Suite 100
state: Ohio
city: Canfield
country: United States
facility: DataPharm, Inc., 6715 Tippecanoe Rd., Bldg E (LL)
state: Ohio
city: Columbus
country: United States
facility: Parsons Avenue Medical Clinic, 1493 Parsons Avenue
state: Ohio
city: Altoona
country: United States
facility: Blair Medical Associates, Inc., Station Medical Center, 1414 Ninth Ave.
state: Pennsylvania
city: Harleysville,
country: United States
facility: Lederach Family Medicine, PC, 658 Harleysville Pike, Suite 120
state: Pennsylvania
city: Harleysville
country: United States
facility: Harleysville Medical Associates, 176 Main Street
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Greentree Medical Associates, 651 Holiday Drive, Foster Plaza Bldg #5
state: Pennsylvania
city: Austin
country: United States
facility: MetaClin Research, Inc., 6012 West William Cannon Drive, 6012 West William Cannon Drive
state: Texas
city: Poth
country: United States
facility: Apollo Research Institute, 117 Dilworth Plaza
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research, Inc., 3590 West 9000 South, Suite 230
state: Utah
Study officials:
affiliation: Adams Respiratory Therapeutics
name: Helmut Albrecht, M.D.
role: STUDY_CHAIR
References: