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 (NCT02875366) enrolled 70 people with cystic fibrosis — 36 in the placebo group and 34 in the group receiving a combination treatment called lumacaftor/ivacaftor (LUM/IVA). All 36 people in the placebo group completed the study, while 31 of the 34 in the LUM/IVA group completed it (3 did not finish). The trial was measuring whether LUM/IVA had any effect on exercise capacity over 24 weeks, primarily by tracking changes in "VO2max" — a measure of the maximum amount of oxygen the body can use during intense exercise, tested on a specialised exercise machine. The reported data shows that for the primary outcome — the percentage change in VO2max from the start of the study to week 24 — the placebo group saw a change of −3.5% and the LUM/IVA group saw a change of −6.6%, meaning both groups showed a decline on average, with the LUM/IVA group's decline being somewhat larger. For the secondary outcomes, exercise duration changed by +0.4% (placebo) versus −2.8% (LUM/IVA) in relative terms, and by −2.1 seconds (placebo) versus −17.4 seconds (LUM/IVA) in absolute terms. The absolute change in VO2max was −1.3 ml/kg/min for placebo and −2.7 ml/kg/min for LUM/IVA. For oxygen consumption at the "anaerobic threshold" — the point during exercise where the body starts to struggle to keep up with oxygen demand — the placebo group showed a change of +94.6 ml/min, while the LUM/IVA group showed a change of −55.1 ml/min. In percentage terms, those figures were +9.4% (placebo) and +1.8% (LUM/IVA). 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 33358691) ↗
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 4 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 two copies of a specific gene change called F508del in the CF (cystic fibrosis) gene
- You have a confirmed cystic fibrosis diagnosis, shown by a sweat test result of 60 mmol/L or higher
- Your CF is considered stable, as judged by the doctor running the trial
- Your lung function (measured by a breathing test) is between 40% and 90% of the expected level for someone your age and size
Who may not be able to join:
- You have another health condition that could affect the study results, interfere with exercise testing, or make taking the study drug risky for you
- You have previously taken the medications lumacaftor (LUM) or ivacaftor (IVA)
- You have a history of irregular heartbeat, heart disease, heart failure, or another significant heart condition, or you regularly take certain heart or blood pressure medications that can affect how well you exercise
- You have previously had a transplant of an organ (such as a kidney or liver) or bone marrow/blood stem cells
- If you are under 18, certain findings from an eye examination done at screening may mean you cannot join, unless you have had both lenses in your eyes removed (confirm with trial site)
- You are currently taking, or expect to need, any medication that is not allowed in this study
- You have had a problem with alcohol or drug misuse (including cannabis, cocaine, or opiates) in the past year, as assessed by the investigator
- You have taken part in another clinical drug trial within the 30 days before your screening visit
- You are pregnant or breastfeeding, or you are a male whose female partner is pregnant or breastfeeding
- You have been found to carry certain bacteria or germs in your lungs that are linked to faster worsening of lung health
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
11 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.