Study to Evaluate the Effects of Oral Glyceryl Guiacolate (Guaifenesin, GGE) on Sputum Rheology in Subjects With Mucus Hypersecretion

Prior treatment

• • 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.
  • 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.

• • 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.