Phase
Condition
Bronchiectasis
Bronchitis
Chronic Bronchitis
Treatment
Guafenesin tablets
Clinical Study ID
Ages 40-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients with a diagnosis of SCB at recruitment, male and female, over 40years of age
A Pulmonary Function Test with FEV1/FVC less than 0.7 (70%) at the time ofenrollment or at least a 10 year history of cigarette abuse.
Patients who have chronic sputum production 3 months out of the year for 2consecutive years and a productive cough as part of their symptoms.
Patients who understand and are able to fill out a questionnaire and ePRO weekly
Patients who have not used guaifenesin containing products within one month of thetime of study enrollment
Patients with 6 to 12 (ideally 12)-month historical data - retrieved from eitherelectronic medical records (EMR), electronic health records (EHRs), or provided bythe patient via interview.
Rescue medicine:
• No rescue medicine will be provided. Information regarding concurrent rescue medications, either OTC or via prescription, will be collected.
Exclusion
Exclusion Criteria:
Patients who are pregnant or breastfeeding
Participation in another study involving an investigational product within 30 daysof the baseline visit
Pulmonary diagnosis other than CB, (such as cystic fibrosis, alpha-1 antitrypsindeficiency, bronchiectasis, or pulmonary fibrosis)
Active lung cancer or history of lung cancer if it has been less than 2 years sincelung resection or other treatment including chemotherapy or radiation. If thepatient has a history of lung cancer, they must be in remission
Psychiatric disorder that precludes participation in the study
History of alcohol and/or drug abuse within one year of study start
Patients taking intermittent antibiotics and patients taking oral and systemiccorticosteroids (e.g., prednisone at a dose of > 10 mg/day).
Patients on a chronic stable dose of macrolide antibiotics at the start of the studymay be included at the discretion of the Principal Investigator.
Patients who had an acute exacerbation of chronic bronchitis within a period of onemonth of starting the study that required systematic steroids or antibiotics
Hypersensitivity to guaifenesin, or any other excipient listed in the product.
Study Design
Study Description
Connect with a study center
American Health Research
Charlotte, North Carolina 28277
United StatesSite Not Available
Clinical Research of Rock Hill
Rock Hill, South Carolina 29732
United StatesSite Not Available
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