A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators

You may be eligible if

• Consent
• A. Written informed consent (and assent when applicable) obtained from participant or participant's legal guardian
• B. Is willing and able to adhere to the study visit schedule and other protocol requirements
• Demographics
• A. ≥ 12 years of age at Visit 1
• Medical History
• A. For persons of child-bearing potential: must not be pregnant at Visit 1 or plan to get pregnant during the 12-month study period
• Disease History
• A. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• Sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
• Two well-characterized disease-causing pathogenic variants in the CFTR gene
• or
• One well-characterized disease-causing mutation and a second CFTR variant (with variable or uncharacterized disease-causing potential) and sweat ≥ 30 mmol/liter with permission of the study sponsor-investigators
• B. Clinically stable with no significant changes in health status within the 28 days prior to and including Visit 1
• C. Does not have a history of lung transplantation
• Concomitant Medications
• A. Not genetically eligible for a CFTR modulator according to product label indications and/or No use of CFTR modulator for 28 days prior to Visit 1 with no intent to start or restart during the study period
• B. No use of an investigational drug within 90 days prior to and including Visit 1
• C. Not currently participating in an interventional drug or device trial. Participation in long-term safety follow-up studies (without redosing) and/or behavioral intervention trials is allowed.
• D. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within 28 days prior to and including Visit 1
• E. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Visit 1