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Research to improve treatments for cystic fibrosis patients not on modulators

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

Observational Seattle Children's Hospital · NCT06504589

This study is trying to find better treatments for people with cystic fibrosis who aren't using current medications by collecting health information and samples to help guide future research.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages12 Years and up
SexAll
SponsorSeattle Children's Hospital Academic / other
Locations68 sites (Birmingham, Alabama and 67 other locations)
Trial IDNCT06504589 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 12 and older with a confirmed diagnosis of cystic fibrosis who are not currently taking CFTR modulators.

Not a fit: Patients who are currently taking CFTR modulators or do not have a confirmed diagnosis of cystic fibrosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of new treatments specifically for cystic fibrosis patients who are ineligible for or not taking CFTR modulators.

How similar studies have performed: Other studies focusing on cystic fibrosis have shown success in advancing treatment options, but this specific approach targeting non-modulator patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 67 other locations

+18 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cystic Fibrosisineligible and/or not taking CFTR modulatorsPeople with CF
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.