BronchitisPhase 4NCT07873632
Study to Evaluate the Effects of Oral Glyceryl Guiacolate (Guaifenesin, GGE) on Sputum Rheology in Subjects With Mucus Hypersecretion
A Phase 4 study testing Glycerol Guiacolate in people with Bronchitis and Bronchitis, Chronic, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
A Randomized, Dosing vs Standard of Care, Single-Center, Multiple Dose Study to Evaluate the Effects of Oral Glyceryl Guiacolate (Guaifenesin, GGE) on Sputum Rheology in Subjects With Mucus Hypersecretion Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Bronchitis, Bronchitis, Chronic
- What is being tested?
- Glycerol Guiacolate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 31 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Confirmed diagnosis of stable chronic bronchitis (defined as subjects with chronic productive cough that occurs daily for at least 3 months in 2 consecutive years, in a patient who has not had an acute exacerbation within the previous 4 weeks; where an acute exacerbation of chronic bronchitis is defined as an acute worsening of a patient's symptoms, beyond normal day-to-day variations, necessitating a change in treatment with antibiotics and/or corticosteroids).
- Ability to produce spontaneous sputum and non-reactive to hypertonic saline for induced sputum collection.
- Stable disease (no exacerbations requiring hospitalization in the past 28 days).
- A Pulmonary Function Test with Forced Expiratory Volume in 1st second (FEV1) FEV1/Forced Vital Capacity (FVC) less than 0.7 (70%) but greater than 0.4 (40%) at the time of enrollment and at least a 10-year history of cigarette use.
- Participants who have not used guaifenesin-containing products within one month of the time of study enrollment.
- Adults age 40-75 with stable chronic bronchitis with persistent cough.
Who cannot join
- • Current use of mucolytics (e.g., N-acetylcysteine), corticosteroids, or other GGEs known to alter mucus properties.
- Severe comorbidities (e.g., Gastroesophageal Reflux Disease (GERD), heart failure, advanced Chronic Obstructive Pulmonary Disease (COPD,) or cystic fibrosis).
- Smokers (within the past year). Note: Participants with a positive cotinine test at the baseline visit will be dropped from the study.
- Recent viral infection or other pulmonary exacerbation (< 1 month).
- Participants who are pregnant or breastfeeding.
- Pulmonary diagnosis other than Chronic Bronchitis (CB) (such as cystic fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, or pulmonary fibrosis) or active lung cancer.
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- Participation in another study involving an investigational product within 30 days of the baseline visit.
- Known allergy to the study GGE or its components.
- History of alcohol and/or drug abuse within one year of study start.
- Participants taking intermittent antibiotics and participants taking oral and systemic corticosteroids (e.g., prednisone at a dose of > 10 mg/day). (Note: Participants on a chronic stable dose of macrolide antibiotics at the start of the study may be included at the discretion of the Principal Investigator.)
- Participants who had an acute exacerbation of chronic bronchitis within one month of starting the study that required systemic steroids or antibiotics.
- Hypersensitivity to hypertonic saline, guaifenesin, or any other excipient listed in the product.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Marsico Lung Institute
Chapel Hill, North Carolina, 27599
Wayne Anderson, MEd, PhD, 9197498526, wayne_anderson@med.unc.edu
Carole Robinette, MS, CPFT, ACSM:CEP, carole_robinette@med.unc.edu
About this study
Official title: A Randomized, Dosing vs Standard of Care, Single-Center, Multiple Dose Study to Evaluate the Effects of Oral Glyceryl Guiacolate (Guaifenesin, GGE) on Sputum Rheology in Subjects With Mucus Hypersecretion
A Randomized, Dosing vs Standard of Care, Single-Center, Multiple Dose Study to Evaluate the Effects of Oral Glyceryl Guiacolate (Guaifenesin, GGE) on Sputum Rheology in Subjects With Mucus Hypersecretion
Read the detailed description
The objective is to confirm GGE's impact on transforming mucus to optimal form that facilitates its loosening from airway walls and improves mucociliary clearance. The investigators propose a standard of care (SOC defined as all current medications prescription and non-prescription drugs and supplements) controlled clinical trial involving 40 participants (20 GGE / 20 SOC) with stable chronic bronchitis ((defined as subjects with chronic productive cough that occurs daily for at least 3 months in 2 consecutive years, in a patient who has not had an acute exacerbation within the previous 4 weeks; where an acute exacerbation of chronic bronchitis is defined as an acute worsening of a patient's symptoms, beyond normal day-to-day variations, necessitating a change in treatment with antibiotics and/or corticosteroids)). The trial will collect sputum samples before (baseline) and after 14 \& 28 days of daily GGE/SOC administration and assess rheological properties to quantify changes in sputum viscosity, elasticity, and flow properties. These measurements will be evaluated to elucidate whether GGE reduces mucus rigidity and adhesiveness, facilitating clearance by cilia and coughing, while providing insights into its molecular and physiological effects. Mucus plugging will be assessed by CT lung imaging to determine if lung imaging could act as an outcome measure of the effect of GGE/SOC. This integrated approach aims to advance understanding of outcomes to assess GGE's therapeutic potential and guide future research for respiratory diseases characterized by thickened mucus.
- Conditions
- Bronchitis, Bronchitis, Chronic
- Being tested
- Glycerol Guiacolate, SOC (Standard of care)
- Keywords
- Mucinex, Stable Chronic Bronchitis, Mucus Rheology, Mucus Plugging
- Medical subject headings
- Bronchitis, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycerol GuiacolateDrug
Also called Mucinex
Participants will receive 28 days (+3 days for flexible scheduling) dosing of Glycerol Guiacolate (GGE) (2 x 600 mg for a total of 1200mg) taken twice daily (total of 2400 mg) in addition to current medications.
SOC (Standard of care)Drug
Current medication excluding mucolytics or steroids
| Study group | Role | What they receive |
|---|---|---|
| Glycerol Guiacolate | Experimental | Glycerol Guiacolate (Mucinex) Extended release 2 x 600 mg tablets bis in die (BID) Receives: Drug: Glycerol Guiacolate |
| Standard of Care | Other | Current medication Participant is currently using Receives: Drug: SOC (Standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mucus viscosity
measurement of mucus viscosity
Measured: Baseline to end of treatment (Day 28)
Change in mucus elasticity
measurement of mucus elasticity
Measured: Baseline to end of treatment (Day 28)
Change in mucus concentration
measurement of mucus concentration
Measured: Baseline to end of treatment (Day 28)
Secondary outcomes (1)
CT Quantitation of airway mucus plugs
Change in mucus plug score from baseline to day 28. Segments will be scored as 0 (absent) or 1 (present) for mucus plugs. A total segment score ranging from 0 to 18 for each patient will be calculated. A decrease in the mucus plug score reflects a beneficial finding.
Measured: Baseline to day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Dosing vs Standard of Care, Single-Center, Multiple Dose Pilot Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Reckitt Benckiser Healthcare (UK) Limited
- Responsible party
- Sponsor
- Investigators
- Brian Button, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873632
- Sponsor's protocol ID
- 26-0838
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Dosing vs Standard of Care, Single-Center, Multiple Dose Study to Evaluate the Effects of Oral Glyceryl Guiacolate (Guaifenesin, GGE) on Sputum Rheology in Subjects With Mucus Hypersecretion
- ClinicalTrials.gov ID
- NCT07873632
- Acronym / sponsor ID
- 26-0838
- Conditions
- Bronchitis, Bronchitis, Chronic
- Keywords
- Mucinex, Stable Chronic Bronchitis, Mucus Rheology, Mucus Plugging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Reckitt Benckiser Healthcare (UK) Limited
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 14 Oct 2026 (actual)
- 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.
A Randomized, Dosing vs Standard of Care, Single-Center, Multiple Dose Study to Evaluate the Effects of Oral Glyceryl Guiacolate (Guaifenesin, GGE) on Sputum Rheology in Subjects With Mucus Hypersecretion
Detailed description
The objective is to confirm GGE's impact on transforming mucus to optimal form that facilitates its loosening from airway walls and improves mucociliary clearance. The investigators propose a standard of care (SOC defined as all current medications prescription and non-prescription drugs and supplements) controlled clinical trial involving 40 participants (20 GGE / 20 SOC) with stable chronic bronchitis ((defined as subjects with chronic productive cough that occurs daily for at least 3 months in 2 consecutive years, in a patient who has not had an acute exacerbation within the previous 4 weeks; where an acute exacerbation of chronic bronchitis is defined as an acute worsening of a patient's symptoms, beyond normal day-to-day variations, necessitating a change in treatment with antibiotics and/or corticosteroids)). The trial will collect sputum samples before (baseline) and after 14 \& 28 days of daily GGE/SOC administration and assess rheological properties to quantify changes in sputum viscosity, elasticity, and flow properties. These measurements will be evaluated to elucidate whether GGE reduces mucus rigidity and adhesiveness, facilitating clearance by cilia and coughing, while providing insights into its molecular and physiological effects. Mucus plugging will be assessed by CT lung imaging to determine if lung imaging could act as an outcome measure of the effect of GGE/SOC. This integrated approach aims to advance understanding of outcomes to assess GGE's therapeutic potential and guide future research for respiratory diseases characterized by thickened mucus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Dosing vs Standard of Care, Single-Center, Multiple Dose Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Glycerol Guiacolate | Experimental | Drug: Glycerol GuiacolateGlycerol Guiacolate (Mucinex) Extended release 2 x 600 mg tablets bis in die (BID) |
| Standard of Care | Other | Drug: SOC (Standard of care)Current medication Participant is currently using |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Confirmed diagnosis of stable chronic bronchitis (defined as subjects with chronic productive cough that occurs daily for at least 3 months in 2 consecutive years, in a patient who has not had an acute exacerbation within the previous 4 weeks; where an acute exacerbation of chronic bronchitis is defined as an acute worsening of a patient's symptoms, beyond normal day-to-day variations, necessitating a change in treatment with antibiotics and/or corticosteroids).
Key exclusion criteria (13 listed)
- • Current use of mucolytics (e.g., N-acetylcysteine), corticosteroids, or other GGEs known to alter mucus properties.
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 |
|---|---|---|
| Glycerol GuiacolateAlso: MucinexParticipants will receive 28 days (+3 days for flexible scheduling) dosing of Glycerol Guiacolate (GGE) (2 x 600 mg for a total of 1200mg) taken twice daily (total of 2400 mg) in addition to current medications. | Drug | Glycerol Guiacolate |
| SOC (Standard of care)Current medication excluding mucolytics or steroids | Drug | Standard of Care |
Primary outcome
Change in mucus viscosity
Time frame: Baseline to end of treatment (Day 28)
measurement of mucus viscosity
Change in mucus elasticity
Time frame: Baseline to end of treatment (Day 28)
measurement of mucus elasticity
Change in mucus concentration
Time frame: Baseline to end of treatment (Day 28)
measurement of mucus concentration
1 secondary outcome
CT Quantitation of airway mucus plugs
Time frame: Baseline to day 28.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Brian Button, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glycerol Guiacolate in people with Bronchitis and Bronchitis, Chronic, 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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 14 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Button, PhD (919-966-8073, brian_button@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mucus viscosity (time frame: Baseline to end of treatment (Day 28)). 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 14 Oct 2026.