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:
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:
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
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:
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