Phase 4 Study - Mucinex D as Adjunct Therapy

This study has been completed.
Sponsor:
Information provided by:
Adams Respiratory Therapeutics
ClinicalTrials.gov Identifier:
NCT00441246
First received: February 26, 2007
Last updated: February 5, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Infection
Bronchitis
Rhinosinusitis
Drug: Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Adams Respiratory Therapeutics:

Primary Outcome Measures:
  • 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. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2007
Study Completion Date: July 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441246

  Show 28 Study Locations
Sponsors and Collaborators
Adams Respiratory Therapeutics
Investigators
Study Chair: Helmut Albrecht, M.D. Adams Respiratory Therapeutics
  More Information

No publications provided

Responsible Party: Timothy Shea, Adams RT
ClinicalTrials.gov Identifier: NCT00441246     History of Changes
Other Study ID Numbers: 2007-MUCD-001
Study First Received: February 26, 2007
Last Updated: February 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Adams Respiratory Therapeutics:
Acute Respiratory Infection
Bronchitis
Rhinosinusitis

Additional relevant MeSH terms:
Bronchitis
Respiratory Tract Infections
Sinusitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Infection
Paranasal Sinus Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Guaifenesin
Phenylpropanolamine
Pseudoephedrine
Chlorpheniramine, phenylpropanolamine drug combination
Ephedrine
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics

ClinicalTrials.gov processed this record on August 18, 2014