Acute Respiratory InfectionPhase 2MCC/CCNCT01114581
Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
A Phase 2 study testing Mucinex in people with Acute Respiratory Infection, run by Reckitt Benckiser LLC at 1 site in United States.
Trial summary
The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Respiratory Infection
- What is being tested?
- Mucinex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of cough, thickened mucus and chest congestion
- Able to produce sputum
- Non Smoker
Who cannot join
- Pregnant
- Smokers
- Fever above 101°F
- Any chronic illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Environmental Medicine, Asthma, and Lung Biology
Chapel Hill, North Carolina, 27599
About this study
The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.
- Conditions
- Acute Respiratory Infection
- Being tested
- Mucinex, Placebo
- Keywords
- Acute Respiratory Infection, Mucociliary, Cough Clearance, Guaifenesin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucinexDrug
Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study
PlaceboDrug
Placebo given as 2 tablets
| Study group | Role | What they receive |
|---|---|---|
| Guaifenesin | Active comparator | Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets Receives: Drug: Mucinex |
| Placebo | Placebo comparator | Given as 2 tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
Percentage of inhaled radioactive tracer (Ave180Clear)
Measured: 3 hours following inhalation of radioactive tracer particles
Secondary outcomes (2)
Guaifenesin AUC(0-3)
Measured: 3 hours following dose administration
Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.
Measured: Within 10 days of developing symptoms associated with a respiratory tract infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionApr 2011
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Bennett, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114581
- Sponsor's protocol ID
- 2010-MUC-01
- Acronym
- MCC/CC
- Status last verified
- Aug 2018
- First submitted
- 28 Apr 2010
- Last updated
- 19 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bennett WD, Kala A, Duckworth H, Zeman KL, Wu J, Henderson A, Yopp M, Rubin BK. Effect of a single 1200 Mg dose of Mucinex(R) on mucociliary and cough clearance during an acute respiratory tract infection. Respir Med. 2015 Nov;109(11):1476-83. doi: 10.1016/j.rmed.2015.09.017. Epub 2015 Oct 9.
PubMed 26462765
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
- ClinicalTrials.gov ID
- NCT01114581
- Acronym / sponsor ID
- MCC/CC / 2010-MUC-01
- Conditions
- Acute Respiratory Infection
- Keywords
- Acute Respiratory Infection, Mucociliary, Cough Clearance, Guaifenesin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Reckitt Benckiser LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Posted 8 Oct 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 research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guaifenesin | Active comparator | Drug: MucinexMucinex 1200mg (Guaifenesin)given as 2, 600mg tablets |
| Placebo | Placebo comparator | Drug: PlaceboGiven as 2 tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptoms of cough, thickened mucus and chest congestion
- Able to produce sputum
- Non Smoker
Key exclusion criteria (4 listed)
- Pregnant
- Smokers
- Fever above 101°F
- Any chronic illness
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 |
|---|---|---|
| MucinexMucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study | Drug | Guaifenesin |
| PlaceboPlacebo given as 2 tablets | Drug | Placebo |
Primary outcome
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
Time frame: 3 hours following inhalation of radioactive tracer particles
Percentage of inhaled radioactive tracer (Ave180Clear)
2 secondary outcomes
Guaifenesin AUC(0-3)
Time frame: 3 hours following dose administration
Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.
Time frame: Within 10 days of developing symptoms associated with a respiratory tract infection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26462765Bennett WD, Kala A, Duckworth H, Zeman KL, Wu J, Henderson A, Yopp M, Rubin BK. Effect of a single 1200 Mg dose of Mucinex(R) on mucociliary and cough clearance during an acute respiratory tract infection. Respir Med. 2015 Nov;109(11):1476-83. doi: 10.1016/j.rmed.2015.09.017. Epub 2015 Oct 9.
Related trials for Acute Respiratory Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
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.
William Bennett, PhD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mucinex in people with Acute Respiratory Infection, run by Reckitt Benckiser LLC at 1 site 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 3 inclusion and 4 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Oct 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?
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs (time frame: 3 hours following inhalation of radioactive tracer particles). 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 NCT01114581, 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 19 Sep 2018.