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 (NCT03559062) enrolled 67 people in total across three groups: 10 received a placebo (a dummy treatment), 54 received a combination called TEZ/IVA (tezacaftor/ivacaftor), and 3 received ivacaftor alone. The trial was looking at a lung function measure called the Lung Clearance Index (LCI2.5) — essentially a test of how efficiently air moves through the lungs, where a lower number generally reflects more even airflow. It also looked at sweat chloride levels (a common marker measured in cystic fibrosis), a quality-of-life questionnaire focused on breathing symptoms, and the number of people who experienced side effects. All measurements were taken over 8 weeks. The reported data shows that, in the TEZ/IVA group, the average LCI2.5 score changed by −0.51 units from the start to week 8. Sweat chloride levels changed by an average of −12.3 mmol/L (millimoles per litre) over the same period. Scores on the respiratory symptoms questionnaire — which runs from 0 to 100, with higher scores meaning fewer symptoms — changed by an average of +2.3 points in the TEZ/IVA group. These figures represent average changes from each participant's starting point; the data for the placebo and ivacaftor-only groups was not reported for these outcome measures. The reported data shows that, when it came to side effects (called adverse events), 8 out of 10 people in the placebo group, 41 out of 54 in the TEZ/IVA group, and 2 out of 3 in the ivacaftor group experienced at least one treatment-emergent adverse event. No serious adverse events were reported in any of the three groups. 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 37983082) ↗
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 must have a specific genetic makeup related to cystic fibrosis — either two copies of the F508del gene mutation, or one copy of F508del plus another specific type of mutation (confirm with trial site for exact mutation details)
- Your lung function test result (measuring how much air you can breathe out) must be 70% or above of what is considered normal for your age, sex, and height
- A specific breathing test called LCI2.5 must show a result of 7.5 or higher, which measures how evenly air moves in and out of your lungs (confirm with trial site)
- You must be able to swallow tablets
Who may not be able to join:
- You have serious liver scarring (cirrhosis), with or without increased pressure in the liver's blood vessels
- Your lungs are colonised with certain bacteria or organisms known to cause a faster decline in lung health (confirm with trial site for specific organisms)
- You have previously received a transplant of a solid organ (such as a kidney or liver) or a blood/bone marrow transplant
Important: 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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Absolute Change in Lung Clearance Index 2.5 (LCI2.5) Through Week 8
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.