NCT06504589 A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
| NCT ID | NCT06504589 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nicole Hamblett |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-09-18 |
| Primary Completion | 2029-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2024-09-18 with a primary completion date of 2029-08-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 data and specimens, from people with CF who do not take CFTR modulators. This data may be used to inform CF research, help design CF clinical trials and support the development of new treatments for people with CF who do not take CFTR modulators. Another goal of this study is to learn about research involvement for people with CF who do not take CFTR modulators, engage them in research, and give them an opportunity to learn about what is involved in participating in a CF research study.
Eligibility Criteria
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
Contact & Investigator
Deepika Polineni, MD, MPH
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT06504589 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06504589 currently recruiting?
Yes, NCT06504589 is actively recruiting participants. Contact the research team at olena.boyarska@seattlechildrens.org for enrollment information.
Where is the NCT06504589 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Tucson, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT06504589 clinical trial?
NCT06504589 is sponsored by Nicole Hamblett. The principal investigator is Deepika Polineni, MD, MPH at Washington University School of Medicine. The trial plans to enroll 400 participants.