On October 7, 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.
ASSURE: Study of Relizorb in people with CF who receive enteral tube feeding
Description: This open label study is taking place at multiple care centers across the U.S. It will look at the safety, tolerability and effectiveness of Relizorb, a new digestive enzyme cartridge for people using enteral tube feedings.
Age: 4 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: Less than 100%
Number of Visits: 5
Length of Participation: 4 months
ClinicalTrial.gov link: https://www.clinicaltrials.gov/ct2/show/NCT02750501
Description: This study evaluated if continuous alternating treatment with two different types of inhaled antibiotics [Aztreonam for Inhalation Solution (Cayston®) and Tobramycin Inhalation Solution (TIS)] , resulted in better outcomes than an intermittent regimen (28 days on/28 days off) of TIS.
Age: 6 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 25 to 75%
Number of Visits: 9
Length of Participation: 7 months
ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT01641822
Burlulipase in People with CF and Pancreatic Insufficiency
Description: This crossover study tested the effectiveness of burlulipase on fat absorption in people with CF and pancreatic insufficiency.
Age: 12 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: No FEV1 Limit
Number of Visits: 4
Length of Participation: 5 weeks
ClinicalTrial.gov link: https://clinicaltrials.gov/show/NCT01710644
Ivacaftor in People with CF age 2 to 5 years with a CFTR Gating Mutation
Description: This was an open-label study designed to look at the safety and effectiveness of ivacaftor (Kalydeco®) in children with CF who had at least one copy of a CFTR gating mutation.
Age: 2 Years to 5 Years
Mutation: One Copy F508del or No Copies F508del
Fev1% Predicted: No FEV1 Limit
Number of Visits: 11
Length of Participation: 32 weeks
ClinicalTrial.gov link: https://clinicaltrials.gov/show/NCT01705145
Levofloxacin Inhalation Solution (Aeroquin™) compared to TOBI® in people with Cystic Fibrosis
Description: This study looked at the safety and effectiveness of levofloxacin inhalation solution (AEROQUIN™), compared to tobramycin solution for inhalation (TIS in people with CF who had chronic Pseudomonas aeruginosa lung infection.
Age: 12 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 25 to 85%
Number of Visits: 10
Length of Participation: 6 months
ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT01270347