CFF provided a series of clinical trial updates in March 2017. Click the trial title to get more details.

The following alert was distributed March 29, 2017:

Phase 3 study of Vertex 661 and ivacaftor in people with CF who have one copy of the F508del-CFTR mutation and a second CFTR mutation predicted to have residual function

Description: This study is taking place at multiple care centers across the U.S. It will look at the safety and effectiveness of the drug VX-661 in combination with ivacaftor and will use a placebo control.

Age: 12 Years and Older

Mutation: One Copy F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 12

Length of Participation: 33 weeks

ClinicalTrials.gov link:  https://www.clinicaltrials.gov/ct2/show/NCT02392234

The following alert was distributed March 16, 2017:

VX 809 and ivacaftor in people with CF who are aged 12 years and older and have two copies of the F508del-CFTR mutation (105)

Description: This was an open-label follow-on study that evaluated the safety and efficacy of lumacaftor in combination with ivacaftor (Orkambi®) in people with CF, 12 years and older and who have two copies of the F508del genetic mutation.

Age: 12 Years and Older

Mutation: Two Copies F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 7

Length of Participation: 96 weeks

ClinicalTrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT01931839

SNO4: Study of N91115 in people with cystic fibrosis ages 18 and older with two copies of F508del-CFTR mutation

Description: This study looked at the safety and tolerability of the drug, N91115, in people with CF that had two copies of the F508del mutation. Researchers also looked at the effect of N91115 on CFTR biomarkers, such as sweat chloride value. Biomarkers help researchers understand how active or inactive a disease is.

Age: 18 Years and Older

Mutation: Two Copies F508del

Fev1% Predicted: 40% or greater

Number of Visits: 8

Length of Participation: 6 weeks

ClinicalTrials.gov link:  https://www.clinicaltrials.gov/ct2/show/NCT02275936

The following alert was distributed March 3, 2017:

Early Treatment of New Onset of Methicillan Resistant Staphylococcus Aureus (MRSA) Growth in Respiratory Culture

Description: This study evaluated an eradication protocol to eliminate Methicillin-resistant Staphylococcus aureus (MRSA) from the lungs of people with CF who recently grew the bacteria in a respiratory culture.

Age: 4 Years to 45 Years

Mutation: No Mutation Requirement

Fev1% Predicted: 30% or greater

Number of Visits: 5

Length of Participation: 6 months

ClinicalTrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT01349192