Research to improve treatments for cystic fibrosis patients not on modulators

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The REACH study focuses on individuals with cystic fibrosis (CF) who are not currently taking CFTR modulators. It aims to collect health data and biological specimens from these patients to inform future CF research and clinical trials. By engaging this underserved population, the study seeks to promote innovative trial designs and advance new therapeutic options, including nucleic acid-based therapies. The study will gather longitudinal data to assess outcomes and support the development of effective treatments for those who cannot benefit from existing modulators.

Why it matters

Who can join: the full rules

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

Where it's running

• The Children's Hospital Alabama, University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• Tucson Cystic Fibrosis Center
  Tucson, Arizona, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Childrens Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Stanford University Medical Center
  Palo Alto, California, United States Recruiting

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Deepika Polineni, MD, MPH — Washington University School of Medicine
• Study coordinator: Olena Boyarska
• Email: olena.boyarska@seattlechildrens.org
• Phone: 206-884-1681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.