Acute Upper Respiratory Track InfectionPhase 4Wait and SeeNCT01202279
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
A Phase 4 study testing Guaifenesin in people with Acute Upper Respiratory Track Infection, run by Reckitt Benckiser Inc. at 24 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Upper Respiratory Track Infection
- What is being tested?
- Guaifenesin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,179 participants
- Where
- 24 sitesUnited States
- Study dates
- Oct 2009to Jul 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Integrated Medical Research, PC
Ashland, Oregon, 97520
Immedicenter
Bloomfield, New Jersey, 07003
TriCities Medical Research
Bristol, Tennessee, 37620
Med Center
Carmichael, California, 95608
Parsons Avenue Medical Clinic
Columbus, Ohio, 43207
Legacy Clinical Research, LLC, 1204 W. Willow Road, Suite B
Enid, Oklahoma, 73703
Sterling Research Group, Ltd., 650 Sprucewood Lane
Erlanger, Kentucky, 41018
Research Center of Fresno, 3636 N. First Street, Suite 141
Fresno, California, 93726
Harleysville Medical Associates, 176 Main Street
Harleysville, Pennsylvania, 19438
Peters Medical Research
High Point, North Carolina, 27262
Kastelic MD & Associates, 322 Warren Street, Suite 300
Johnstown, Pennsylvania, 15905
Clinical Research Advantage, Inc.
Mesa, Arizona, 85203
Koch Family Medicine, 81A E. Queenwood Road
Morton, Illinois, 61550
Palmetto Medical Research, 180 Wingo Way, Suite 203
Mt. Pleasant, South Carolina, 29464
Coastal Connecticut Research, LLC, 342 Montauk Avenue
New London, Connecticut, 06320
Glasgow Family Practice
Newark, Delaware, 19702
Durham Physicians, P.C.
Penndel, Pennsylvania, 19047
Village Health Partners
Plano, Texas, 75024
Clinical Associates Research, 750 Main Street, Suite 310
Reisterstown, Maryland, 21136
(Piedmont Medical Research Assoc., Inc. d/b/a), Crescent Medical Research
Salisbury, North Carolina, 28144
Coastal Medical Research Group, Inc., 47 Santa Rosa Street
San Luis Obispo, California, 93405
Park Place Family Practice & Internal Medicine
Taylor, Michigan, 48180
Independence Family Medicine, 813 Independence Blvd., Suite A
Virginia Beach, Virginia, 23455
Amherst Family Practice, 1867 Amherst Street
Winchester, Virginia, 22601
About this study
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
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
- Conditions
- Acute Upper Respiratory Track Infection
- Being tested
- Guaifenesin, Placebo
- Keywords
- Acute Upper Respiratory Track Infection Who Seek Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuaifenesinDrug
Also called Mucinex D, Mucinex, Pseudoephedrine
1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days
PlaceboDevice
Placebo bid for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Mucinex D | Active comparator | 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 Receives: Drug: Guaifenesin |
| Placebo | Placebo comparator | Placebo given bid with a full glass of water for 7 days Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic Sparing
Number of patients who received an antibiotic
Measured: Day 7
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.
Measured: Baseline and 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Respiratory Track 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202279
- Sponsor's protocol ID
- 2009-MUCD-001
- Acronym
- Wait and See
- Status last verified
- Dec 2020
- First submitted
- 13 Sep 2010
- Last updated
- 30 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28761581
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01202279
- Acronym / sponsor ID
- Wait and See / 2009-MUCD-001
- Conditions
- Acute Upper Respiratory Track Infection
- Keywords
- Acute Upper Respiratory Track Infection Who Seek Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,179 participants (actual)
- Lead sponsor
- Reckitt Benckiser Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Posted 5 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucinex D | Active comparator | Drug: GuaifenesinMucinex 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 | Placebo comparator | Device: PlaceboPlacebo given bid with a full glass of water for 7 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| GuaifenesinAlso: Mucinex D, Mucinex, Pseudoephedrine1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days | Drug | Mucinex D |
| PlaceboPlacebo bid for 7 days | Device | Placebo |
Primary outcome
Antibiotic Sparing
Time frame: Day 7
Number of patients who received an antibiotic
Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
Time frame: Baseline and 7 Days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28761581Septimus 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
24 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 Guaifenesin in people with Acute Upper Respiratory Track Infection, run by Reckitt Benckiser Inc. at 24 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 1 inclusion and 1 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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Antibiotic Sparing (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01202279, which also lists 1 linked publication.
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 30 Dec 2020.