Mucociliary ClearancePhase 1NCT00902707
Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung
A Phase 1 study testing Mucinex 1200mg in people with Mucociliary Clearance, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucociliary Clearance
- What is being tested?
- Mucinex 1200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2012
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Non smoker
- BMI 19-29
- Normal lung function
Who cannot join
- Pregnant
- Smokers
- Any illness
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599
About this study
Official title: An Open-Label, 2-way Crossover Placebo-Controlled , Radio-Labeled Tracer Study Evaluating the Effect of MUCINEX® 1200 mg on Mucociliary and Cough Clearance From The Human Lung In Healthy, Non-Smoking Adults
The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
- Conditions
- Mucociliary Clearance
- Being tested
- Mucinex 1200mg, Placebo
- Keywords
- healthy nonsmokers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucinex 1200mgDrug
Compared to Placebo
PlaceboDrug
Compare to active Mucinex
| Study group | Role | What they receive |
|---|---|---|
| Mucinex 1200mg | Experimental | Pill Receives: Drug: Mucinex 1200mg |
| Placebo | Placebo comparator | Pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between drug and placebo in the percentage of particles cleared from the lung.
Measured: Measurements at 60, 90 and 180 min
Difference between drug and placebo as an estimate of small airway clearance.
Measured: Measurements at 60, 90 and 180 min
Difference between drug and placebo between study days.
Measured: Measurements at 60, 90 and 180 min
Secondary outcomes (1)
Blood will be drawn to determination of guaifenesin in the serum.
Measured: at baseline and every 30 min x8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucociliary ClearanceStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Reckitt Benckiser Inc.
- Responsible party
- Principal investigator, William Bennett, PhD, University of North Carolina, Chapel Hill
- Investigators
- William Bennett, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902707
- Sponsor's protocol ID
- 2009-MUC-01
- Status last verified
- May 2012
- First submitted
- 13 May 2009
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 2-way Crossover Placebo-Controlled , Radio-Labeled Tracer Study Evaluating the Effect of MUCINEX® 1200 mg on Mucociliary and Cough Clearance From The Human Lung In Healthy, Non-Smoking Adults
- ClinicalTrials.gov ID
- NCT00902707
- Acronym / sponsor ID
- 2009-MUC-01
- Conditions
- Mucociliary Clearance
- Keywords
- healthy nonsmokers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Reckitt Benckiser Inc.
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 May 2009 (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 purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucinex 1200mg | Experimental | Drug: Mucinex 1200mgPill |
| Placebo | Placebo comparator | Drug: PlaceboPill |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Non smoker
- BMI 19-29
- Normal lung function
Key exclusion criteria (3 listed)
- Pregnant
- Smokers
- Any 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 |
|---|---|---|
| Mucinex 1200mgCompared to Placebo | Drug | Mucinex 1200mg |
| PlaceboCompare to active Mucinex | Drug | Placebo |
Primary outcome
Difference between drug and placebo in the percentage of particles cleared from the lung.
Time frame: Measurements at 60, 90 and 180 min
Difference between drug and placebo as an estimate of small airway clearance.
Time frame: Measurements at 60, 90 and 180 min
Difference between drug and placebo between study days.
Time frame: Measurements at 60, 90 and 180 min
1 secondary outcome
Blood will be drawn to determination of guaifenesin in the serum.
Time frame: at baseline and every 30 min x8
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 11 Jun 2012.
Related trials for Mucociliary Clearance
RecruitingPhase 4
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Asthma
Not yet recruiting
Effect of Continuous Nebulisation of Isotonic Saline Solution Combined With Heated Humidification on Mucociliary Clearance in Healthy Subjects
Healthy Subjects (HS)
Not yet recruiting
Clearance in Primary Ciliary Dyskinesia
Primary Ciliary Dyskinesia, PCD
RecruitingObservational study
Pathogenesis of Primary Ciliary Dyskinesia (PCD) Lung Disease
Kartagener Syndrome
Enrolling by invitation
Clean Air for Rare MUcociliary Clearance dIsorders
Primary Ciliary Dyskinesia (PCD), Cystic Fibrosis (CF)
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 1 study testing Mucinex 1200mg in people with Mucociliary Clearance, run by University of North Carolina, Chapel Hill 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 4 inclusion and 3 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 11 Jun 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Difference between drug and placebo in the percentage of particles cleared from the lung. (time frame: Measurements at 60, 90 and 180 min). The study lists 3 primary outcomes in all. 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 11 Jun 2012.