Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04058353) enrolled 258 people with cystic fibrosis — 126 in a control group who continued taking an existing cystic fibrosis medicine (either ivacaftor alone or tezacaftor/ivacaftor), and 132 in a group who switched to a triple-drug combination called elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA). The trial was measuring changes in three things: lung function (specifically how much air someone can forcefully breathe out in one second, expressed as a percentage of what is expected for a healthy person of similar age and size — called ppFEV1), a sweat chloride level (a marker commonly measured in cystic fibrosis, where salt concentration in sweat is tested), and a self-reported quality-of-life score focused on breathing symptoms (scored from 0 to 100, where higher means fewer symptoms). The reported data shows that in the triple combination group, ppFEV1 changed by an average of +3.7 percentage points, compared to +0.2 percentage points in the control group. For sweat chloride, the triple combination group saw an average change of −22.3 mmol/L (a fall in the level), while the control group saw a change of +0.7 mmol/L. On the breathing symptom quality-of-life questionnaire, the triple combination group reported an average change of +10.3 points on the 0–100 scale, compared to +1.6 points in the control group. These are the numbers as submitted by the trial sponsor; no other outcome data was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 34437784) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Cystic Fibrosis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have a confirmed diagnosis of cystic fibrosis (CF) and carry one copy of a specific gene change called F508del, along with a second specific type of gene change (called a "gating" or "residual function" mutation
- Your lung function test results (a breathing test called FEV1) fall within a specific range — not too low and not too high — based on what is expected for your age, sex, and height
Who may not be able to join:
- You have significant scarring or damage to your liver, with or without increased blood pressure in the liver's blood vessels
- You have a lung infection caused by certain germs that are known to cause faster decline in lung health (confirm with trial site for which specific organisms apply)
- You have previously received a transplant of a solid organ (such as a kidney, heart, or liver) or of blood-forming cells (such as a bone marrow transplant)
Important: There may be additional requirements not listed here. Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for ELX/TEZ/IVA Group
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.