Remote Sputum Collection for Cystic Fibrosis
(RESCUe Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the effectiveness of home-collected sputum samples (a type of mucus coughed up from the lungs) for diagnosing lung infections in people with cystic fibrosis (CF). It compares the reliability of these samples sent by mail to those collected in a clinic. The study focuses on how the medication combination Elexacaftor/Tezacaftor/Ivacaftor, or Trikafta (a therapy for cystic fibrosis), improves lung health by reducing cough and mucus production. Individuals with cystic fibrosis who can collect samples at home and have access to FedEx services are suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinator or your doctor.
What prior data suggests that remote sputum collection is safe for cystic fibrosis patients?
Research has shown that the medication Elexacaftor/Tezacaftor/Ivacaftor, also known as Trikafta, is generally safe for people with cystic fibrosis (CF). In studies involving over 500 patients aged 12 and older, this treatment was well-tolerated for 24 weeks. Most side effects were mild, but there is a serious risk of liver damage, which can include liver failure. In rare cases, this could necessitate a liver transplant or even result in death. Despite this risk, the long-term safety of Trikafta is considered good, and the FDA has approved it for people with CF who have certain genetic mutations. Always discuss potential risks with a healthcare provider before starting any new treatment.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new method for managing cystic fibrosis that could make life significantly easier for patients. Unlike traditional methods that require frequent hospital visits for sputum collection, this trial examines the possibility of remote sputum collection. This approach could save time, reduce exposure to hospital environments, and provide more consistent monitoring for patients. If successful, it would represent a major step forward in making cystic fibrosis care more accessible and less burdensome.
What evidence suggests that remote sputum collection is effective for diagnosing lung infections in cystic fibrosis?
Studies have shown that Elexacaftor/Tezacaftor/Ivacaftor, also known as Trikafta, greatly improves lung function in people with cystic fibrosis. Research indicates that it leads to fewer hospital and emergency room visits and enhances overall quality of life. Patients have reported fewer breathing problems and better nutrition. This treatment also significantly reduces coughing and mucus. These findings suggest that Trikafta effectively improves lung health and helps manage symptoms in people with cystic fibrosis.678910
Who Is on the Research Team?
Gina Hong, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Participants collect sputum samples at home and send them by mail for comparison with clinic-based samples
Follow-up
Participants are monitored for the accuracy and validity of remotely collected sputum samples
What Are the Treatments Tested in This Trial?
Interventions
- Elexacaftor/Tezacaftor/Ivacaftor
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Cystic Fibrosis Foundation
Collaborator
Citations
Real‐World Evaluation of Outcomes and Safety ...
Elexacaftor/Tezacaftor/Ivacaftor (ETI) therapy has significantly improved clinical outcomes in people with cystic fibrosis (PwCF) carrying ...
LONGITUDE: An observational study of the long-term ...
LONGITUDE is an observational, registry-based cohort study using data from the UK CF Registry to evaluate outcomes of ELX/TEZ/IVA in people aged ≥6 years.
Real-world outcomes and direct care cost before and after ...
Among 494 commercially insured members diagnosed with cystic fibrosis, a meaningful decrease in hospitalizations, emergency department visits, ...
A Meta-Analysis of TRIKAFTA (Elexacaftor/Tezacaftor ...
Conclusion: TRIKAFTA significantly improves lung function, reduces sweat chloride, and enhances quality of life in CF patients with the F508del ...
Real-World Outcomes of Elexacaftor/Tezacaftor/Ivacaftor in ...
Randomized controlled trials of ETI have demonstrated remarkable improvements in lung function, nutritional status, and respiratory symptoms (1, 2). Yet trial ...
Important Safety Information
TRIKAFTA can cause serious liver damage and liver failure. Liver failure leading to transplantation and death has been seen in some people with or without a ...
Safety Profile | TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor ...
Safety data from 510 patients aged 12 years and older with CF with at least one F508del mutation in 2 double‑blind, controlled, Phase 3 trials of 24 weeks ...
Long-Term Safety and Efficacy of Elexacaftor/Tezacaftor/ ...
These results confirm the favorable long-term safety profile and durable disease-modifying clinical benefits of ELX/TEZ/IVA in adolescents and adults with CF.
Elexacaftor-tezacaftor-ivacaftor in people with cystic ...
In December 2020, the US Food and Drug Administration (FDA) approved ETI for pwCF with at least one of 177 non-F508del rare CFTR variants based on in vitro data ...
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in people aged 2 years and older who have at least one copy of the F508del ...
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