Plain-English translation of NCT03525444 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Cystic fibrosis research guide →Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial tested a medication called VX-445, given alongside two other existing CF medications (tezacaftor and ivacaftor), to see if the three-drug combination could improve lung function and health outcomes. The study focused on people with cystic fibrosis who carry a specific pair of genetic mutations—one being the F508del mutation. Researchers compared this new treatment to a placebo over 24 weeks to understand how well the medication worked and whether it was safe.
Many people with cystic fibrosis who have these particular genetic mutations have limited treatment options that target their specific form of the disease. This trial aimed to find out whether this new three-drug combination could help slow lung disease and improve quality of life for this group of patients.
Participants were randomly assigned to receive either the three-drug combination medication or a placebo for 24 weeks. Those in the treatment group took a combination tablet in the morning and an additional evening tablet, while the placebo group received matching tablets without active medication. Throughout the study, participants attended visits where their lung function and overall health were monitored to determine how well the treatment worked.
AI-generated summary from trial data · Sep 24, 2026 · Not medical advice
United States