Clinical trial NCT01202279: Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Safety and Efficacy of Mucinex D for Symptomatic Therapy in Patients With Acute Upper Respiratory Tract Who Seek Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Upper Respiratory Track Infection
Keywords: Acute Upper Respiratory Track Infection Who Seek Treatment
Lead sponsor: Reckitt Benckiser LLC
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 1179
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: PREVENTION

Brief summary: The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo


Eligibility criteria: Inclusion Criteria:

* patients aged 18 to 75 yrs of age presenting at a clinical site with symptoms diagnostic for an acute upper respiratory tract infection within the last 5 days

Exclusion Criteria:

* patients who had chronic, recurring respiratory signs and symptoms due to conditions such as chronic allergic rhinitis, chronic sinusitis or chronic bronchitis which in the investigator's opinion, confounded interpretation of symptom ratings for the acute upper respiratory infection. Also excluded were patients with a fever greater than 101 degrees F.

Primary outcomes:
measure: Antibiotic Sparing
timeFrame: Day 7
measure: Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
timeFrame: Baseline and 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Carmichael
country: United States
facility: Med Center
state: California
city: Fresno
country: United States
facility: Research Center of Fresno, 3636 N. First Street, Suite 141
state: California
city: San Luis Obispo
country: United States
facility: Coastal Medical Research Group, Inc., 47 Santa Rosa Street
state: California
city: New London
country: United States
facility: Coastal Connecticut Research, LLC, 342 Montauk Avenue
state: Connecticut
city: Newark
country: United States
facility: Glasgow Family Practice
state: Delaware
city: Morton
country: United States
facility: Koch Family Medicine, 81A E. Queenwood Road
state: Illinois
city: Erlanger
country: United States
facility: Sterling Research Group, Ltd., 650 Sprucewood Lane
state: Kentucky
city: Reisterstown
country: United States
facility: Clinical Associates Research, 750 Main Street, Suite 310
state: Maryland
city: Taylor
country: United States
facility: Park Place Family Practice & Internal Medicine
state: Michigan
city: Bloomfield
country: United States
facility: Immedicenter
state: New Jersey
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Salisbury
country: United States
facility: (Piedmont Medical Research Assoc., Inc. d/b/a), Crescent Medical Research
state: North Carolina
city: Columbus
country: United States
facility: Parsons Avenue Medical Clinic
state: Ohio
city: Enid
country: United States
facility: Legacy Clinical Research, LLC, 1204 W. Willow Road, Suite B
state: Oklahoma
city: Ashland
country: United States
facility: Integrated Medical Research, PC
state: Oregon
city: Harleysville
country: United States
facility: Harleysville Medical Associates, 176 Main Street
state: Pennsylvania
city: Johnstown
country: United States
facility: Kastelic MD & Associates, 322 Warren Street, Suite 300
state: Pennsylvania
city: Penndel
country: United States
facility: Durham Physicians, P.C.
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Palmetto Medical Research, 180 Wingo Way, Suite 203
state: South Carolina
city: Bristol
country: United States
facility: TriCities Medical Research
state: Tennessee
city: Plano
country: United States
facility: Village Health Partners
state: Texas
city: Virginia Beach
country: United States
facility: Independence Family Medicine, 813 Independence Blvd., Suite A
state: Virginia
city: Winchester
country: United States
facility: Amherst Family Practice, 1867 Amherst Street
state: Virginia
Study officials:
References:
citation: Septimus EJ, Albrecht HH, Solomon G, Shea T, Guenin EP. Extended-Release Guaifenesin/Pseudoephedrine Hydrochloride for Symptom Relief in Support of a Wait-and-See Approach for the Treatment of Acute Upper Respiratory Tract Infections: A Randomized, Double-Blind, Placebo-Controlled Study. Curr Ther Res Clin Exp. 2017 Apr 28;84:54-61. doi: 10.1016/j.curtheres.2017.04.004. eCollection 2017.