Acute Respiratory InfectionPhase 4NCT00441246
Phase 4 Study - Mucinex D as Adjunct Therapy
A Phase 4 study testing Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets) in people with Acute Respiratory Infection and Bronchitis, run by Adams Respiratory Therapeutics at 28 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Respiratory Infection, Bronchitis, Rhinosinusitis
- What is being tested?
- Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 28 sitesUnited States
- Study dates
- Feb 2007to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
DayStar Clinical Research, Inc., 880 Mull Ave., Suite 100
Akron, Ohio, 44313
Blair Medical Associates, Inc., Station Medical Center, 1414 Ninth Ave.
Altoona, Pennsylvania, 16602
MetaClin Research, Inc., 6012 West William Cannon Drive, 6012 West William Cannon Drive
Austin, Texas, 78749
Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214
Birmingham, Alabama, 35235
Immedicenter, 557 Broad St.
Bloomfield, New Jersey, 07003
Central Nebraska Medical Clinic, PC, 145 Memorial Drive
Broken Bow, Nebraska, 68822
DataPharm, Inc., 6715 Tippecanoe Rd., Bldg E (LL)
Canfield, Ohio, 44406
MedCenter, 6651 Madison Ave.
Carmichael, California, 95608
Clinicos, LLC
Colorado Springs, Colorado, 80904
Columbia Medical Practice, 3450 Knoll Dr. North #200C
Columbia, Maryland, 21045
Parsons Avenue Medical Clinic, 1493 Parsons Avenue
Columbus, Ohio, 43207
Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175
Dawsonville, Georgia, 30534
Sterling Research Group, Ltd., 650 Sprucewood Lane
Erlanger, Kentucky, 41018
Harleysville Medical Associates, 176 Main Street
Harleysville, Pennsylvania, 19438
Lederach Family Medicine, PC, 658 Harleysville Pike, Suite 120
Harleysville, Pennsylvania, 19438
Michigan Institute of Medicine, 38525 Eight Mile Rd.
Livonia, Michigan, 48152
Longmont Clinic, P.C., 1925 W. Mountain View Ave.
Longmont, Colorado, 80501
Central New York Clinical Research, RT 92, The Market Place
Manlius, New York, 13104
Milford Emergency Associates, Inc., 14 Asylum St.
Milford, Massachusetts, 01757
Koch Family Medicine, 81A E. Queenwood Rd.
Morton, Illinois, 61550
Welborn Clinic Gateway, 4233 Gateway Blvd
Newburgh, Indiana, 47630
Greentree Medical Associates, 651 Holiday Drive, Foster Plaza Bldg #5
Pittsburgh, Pennsylvania, 15220
Apollo Research Institute, 117 Dilworth Plaza
Poth, Texas, 78114
North Carolina Clinical Research, 4301 Lake Boone Trail, Ste 309-A
Raleigh, North Carolina, 27607
Clinical Associates, 750 Main St. #201
Reisterstown, Maryland, 21136
Torrance Clinical Research, 3640 Lomita Blfd #205
Torrance, California, 90505
Advanced Clinical Research, Inc., 3590 West 9000 South, Suite 230
West Jordan, Utah, 84088
Front Range Clinical Research
Wheat Ridge, Colorado, 80033
About this study
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
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.
- Conditions
- Acute Respiratory Infection, Bronchitis, Rhinosinusitis
- Being tested
- Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)
- Keywords
- Acute Respiratory Infection, Bronchitis, Rhinosinusitis
- Medical subject headings
- Bronchitis, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adams Respiratory Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helmut Albrecht, M.D., Study chair, Adams Respiratory Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441246
- Sponsor's protocol ID
- 2007-MUCD-001
- Status last verified
- Feb 2008
- First submitted
- 26 Feb 2007
- Last updated
- 6 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00441246
- Acronym / sponsor ID
- 2007-MUCD-001
- Conditions
- Acute Respiratory Infection, Bronchitis, Rhinosinusitis
- Keywords
- Acute Respiratory Infection, Bronchitis, Rhinosinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Adams Respiratory TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- May 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 28 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets) | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Albrecht, M.D. study chair
Adams Respiratory Therapeutics
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets) in people with Acute Respiratory Infection and Bronchitis, run by Adams Respiratory Therapeutics at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2008; AzTrials last refreshed its copy on 27 Oct 2026.