Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT05843669
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with a diagnosis of SCB at recruitment, male and female, over 40 years of age
* A Pulmonary Function Test with FEV1/FVC less than 0.7 (70%) at the time of enrollment or at least a 10 year history of cigarette abuse.
* Patients who have chronic sputum production 3 months out of the year for 2 consecutive 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 the time of study enrollment
* Patients with 6 to 12 (ideally 12)-month historical data - retrieved from either electronic medical records (EMR), electronic health records (EHRs), or provided by the 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 Criteria:
* Patients who are pregnant or breastfeeding
* Participation in another study involving an investigational product within 30 days of the baseline visit
* Pulmonary diagnosis other than CB, (such as cystic fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, or pulmonary fibrosis)
* Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment including chemotherapy or radiation. If the patient 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 systemic corticosteroids (e.g., prednisone at a dose of \> 10 mg/day).
* Patients on a chronic stable dose of macrolide antibiotics at the start of the study may be included at the discretion of the Principal Investigator.
* Patients who had an acute exacerbation of chronic bronchitis within a period of one month of starting the study that required systematic steroids or antibiotics
* Hypersensitivity to guaifenesin, or any other excipient listed in the product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT05843669
Study Brief:
Protocol Section:
NCT05843669