Status:
RECRUITING
A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
Lead Sponsor:
Nicole Hamblett
Collaborating Sponsors:
Washington University School of Medicine
Florida State University
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Brief Summary
The REACH study is for people with CF who do not take cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The goal of the REACH study is to collect research data, including health d...
Detailed Description
People with Cystic Fibrosis (pwCF) who are genetically ineligible and/or not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulators currently face future health that is considera...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 14 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06504589
Start Date
September 18 2024
End Date
August 14 2029
Last Update
October 1 2025
Active Locations (68)
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1
The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Tucson Cystic Fibrosis Center
Tucson, Arizona, United States, 85724
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205