On July 29, 2016, the Cystic Fibrosis Foundati0n (CFF) provided alerts on the following clinical trials. The trial title is a link to expanded information on the CFF web site. Additional information may be found through the ClinicalTrials.gov links included with each alert.
Phase 3 study of lumacaftor/ivacaftor in children with CF
Description: This two-part, open-label study is taking place at multiple care centers across the U.S. It will look at the safety and effectiveness of lumacaftor/ivacaftor, as well as how the body processes the drug, in children with CF.
Age: 2 Years to 5 Years
Mutation: Two Copies F508del
Fev1% Predicted: 40% or greater
Number of Visits: 11
Length of Participation: 32 weeks
ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT02797132
Phase 2 study of GS-5745 in adults with CF
Description: This study is taking place at multiple care centers across the U.S. It will look at the effectiveness of the anti-inflammatory drug GS-5745 and will use a placebo control.
Age: 18 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 40 to 80%
Number of Visits: 6
Length of Participation: 24 weeks
ClinicalTrial.gov link: https://www.clinicaltrials.gov/ct2/show/NCT02759562
Phase 4 study of adherence to lumacaftor/ivacaftor in people with CF
Description: This study is taking place at multiple care centers across the U.S. It will look at the impact of using a smart device that monitors medication use on adherence to lumacaftor/ivacaftor.
Age: 16 Years and Older
Mutation: Two Copies F508del
Fev1% Predicted: 40% or greater
Number of Visits: 7
Length of Participation: 48 weeks
ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT02823470
Phase 3 study of ivacaftor in babies who have a CFTR gating mutation
Description: This two-part, open-label study is taking place at multiple care centers across the U.S. It will look at the safety and effectiveness of ivacaftor, as well as how the body processes the drug, in babies who have a CFTR gating mutation.
Age: 0 Months to 24 Months
Mutation: One Copy F508del or No Copies F508del
Fev1% Predicted: No FEV1 Limit
Number of Visits: 8
Length of Participation: 24 weeks
ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT02725567
Levofloxacin Inhalation Solution (Aeroquin™) compared to placebo in people with Cystic Fibrosis
Description: This phase 3 study evaluated the safety and effectiveness of the aerosolized form of the antibiotic, levofloxacin, (AEROQUIN™) in people with CF.
Age: 12 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 25 to 85%
Number of Visits: 6
Length of Participation: 2 months
ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT01180634