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Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI (Wait and See)

Primary Purpose

Acute Upper Respiratory Track Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Guaifenesin
Placebo
Sponsored by
Reckitt Benckiser Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Upper Respiratory Track Infection focused on measuring Acute Upper Respiratory Track Infection Who Seek Treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research Advantage, Inc.
  • Med Center
  • Research Center of Fresno, 3636 N. First Street, Suite 141
  • Coastal Medical Research Group, Inc., 47 Santa Rosa Street
  • Coastal Connecticut Research, LLC, 342 Montauk Avenue
  • Glasgow Family Practice
  • Koch Family Medicine, 81A E. Queenwood Road
  • Sterling Research Group, Ltd., 650 Sprucewood Lane
  • Clinical Associates Research, 750 Main Street, Suite 310
  • Park Place Family Practice & Internal Medicine
  • Immedicenter
  • Peters Medical Research
  • (Piedmont Medical Research Assoc., Inc. d/b/a), Crescent Medical Research
  • Parsons Avenue Medical Clinic
  • Legacy Clinical Research, LLC, 1204 W. Willow Road, Suite B
  • Integrated Medical Research, PC
  • Harleysville Medical Associates, 176 Main Street
  • Kastelic MD & Associates, 322 Warren Street, Suite 300
  • Durham Physicians, P.C.
  • Palmetto Medical Research, 180 Wingo Way, Suite 203
  • TriCities Medical Research
  • Village Health Partners
  • Independence Family Medicine, 813 Independence Blvd., Suite A
  • Amherst Family Practice, 1867 Amherst Street

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mucinex D

Placebo

Arm Description

Mucinex D (1200 mg guaifenesin and 120 mg pseudoephedrine HCl) extended release bilayer tablet twice a day (bid) with a full glass of water for 7 days

Placebo given bid with a full glass of water for 7 days

Outcomes

Primary Outcome Measures

Antibiotic Sparing
Number of patients who received an antibiotic
Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2010
Last Updated
December 3, 2020
Sponsor
Reckitt Benckiser Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01202279
Brief Title
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
Acronym
Wait and See
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Track Infection
Keywords
Acute Upper Respiratory Track Infection Who Seek Treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mucinex D
Arm Type
Active Comparator
Arm Description
Mucinex D (1200 mg guaifenesin and 120 mg pseudoephedrine HCl) extended release bilayer tablet twice a day (bid) with a full glass of water for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given bid with a full glass of water for 7 days
Intervention Type
Drug
Intervention Name(s)
Guaifenesin
Other Intervention Name(s)
Mucinex D, Mucinex, Pseudoephedrine
Intervention Description
1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Placebo bid for 7 days
Primary Outcome Measure Information:
Title
Antibiotic Sparing
Description
Number of patients who received an antibiotic
Time Frame
Day 7
Title
Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
Description
WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.
Time Frame
Baseline and 7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Clinical Research Advantage, Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85203
Country
United States
Facility Name
Med Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Research Center of Fresno, 3636 N. First Street, Suite 141
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Coastal Medical Research Group, Inc., 47 Santa Rosa Street
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Coastal Connecticut Research, LLC, 342 Montauk Avenue
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Glasgow Family Practice
City
Newark
State/Province
Delaware
ZIP/Postal Code
19702
Country
United States
Facility Name
Koch Family Medicine, 81A E. Queenwood Road
City
Morton
State/Province
Illinois
ZIP/Postal Code
61550
Country
United States
Facility Name
Sterling Research Group, Ltd., 650 Sprucewood Lane
City
Erlanger
State/Province
Kentucky
ZIP/Postal Code
41018
Country
United States
Facility Name
Clinical Associates Research, 750 Main Street, Suite 310
City
Reisterstown
State/Province
Maryland
ZIP/Postal Code
21136
Country
United States
Facility Name
Park Place Family Practice & Internal Medicine
City
Taylor
State/Province
Michigan
ZIP/Postal Code
48180
Country
United States
Facility Name
Immedicenter
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
(Piedmont Medical Research Assoc., Inc. d/b/a), Crescent Medical Research
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Parsons Avenue Medical Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Legacy Clinical Research, LLC, 1204 W. Willow Road, Suite B
City
Enid
State/Province
Oklahoma
ZIP/Postal Code
73703
Country
United States
Facility Name
Integrated Medical Research, PC
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Harleysville Medical Associates, 176 Main Street
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Kastelic MD & Associates, 322 Warren Street, Suite 300
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Durham Physicians, P.C.
City
Penndel
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Palmetto Medical Research, 180 Wingo Way, Suite 203
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
TriCities Medical Research
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Village Health Partners
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Independence Family Medicine, 813 Independence Blvd., Suite A
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
Amherst Family Practice, 1867 Amherst Street
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28761581
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.
Results Reference
derived

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Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI

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