Cystic Fibrosis Foundation distributed the following clinical trial updates in January. Click the trial title to get more details.
January 8, 2019
Phase 1/2 study of VX-445 combination drug in healthy adults and then in people with cystic fibrosis
Status: Completed with Results
Description: This study evaluated the safety, tolerability and effectiveness of the drug VX-445 in combination with tezacaftor/ivacaftor (Symdeko®) in people who either have two copies of the F508del CFTR mutation or have one copy of F508del and one copy of a minimal function CFTR mutation.
Age: 18 Years and Older
Mutation: Two Copies F508del or One Copy F508del
Fev1% Predicted: 40 to 90%
Number of Visits: 6
Length of Participation: 12 weeks
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03227471
SOLUTION: Study of Liprotamase in people with CF
Status: Completed with Results
Description: This study evaluated the safety and effectiveness of the drug liprotamase in people with CF who were taking digestive enzymes.
Age: 7 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 30% or greater
Number of Visits: 10
Length of Participation: 28 weeks
ClinicalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT02279498
Persistent Methicillin Resistant Staphylococcus Aureus (MRSA) Growth in Respiratory Culture
Status: Completed with Results
Description: This study evaluated the safety and effectiveness of inhaled vancomycin to eliminate the bacterium, methicillin-resistant Staphylococcus aureus (MRSA) in people with CF who have persistent MRSA infection.
Age: 12 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 40% or greater
Number of Visits: 7
Length of Participation: 8 months
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT01594827
January 24, 2019
Study of SPI-1005 in people with CF ages 18 and older
Status: Enrolling
Description: This study will test the safety and tolerability of SPI-1005, a drug intended to prevent and treat hearing loss caused by aminoglycosides.
Age: 18 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 40 to 100%
Number of Visits: 6
Length of Participation: 49 days
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02819856
January 25, 2019
Phase 2 study of VX-659 combination drug in adults with cystic fibrosis
Status: Completed with Results
Description: This study evaluated the safety, tolerability and effectiveness of the drug VX-659 in combination with tezacaftor/ivacaftor (Symdeko®) in people who either have two copies of the F508del CFTR mutation or have one copy of F508del and one copy of a minimal function CFTR mutation.
Age: 18 Years and Older
Mutation: Two Copies F508del or One Copy F508del
Fev1% Predicted: 40% or greater
Number of Visits: 6
Length of Participation: 8 weeks
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03224351
Status: Completed with Results
Description: Part A of the PROSPECT study identified biomarkers of CFTR function that could be used to monitor disease progression.
Age: 6 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: No FEV1 Limit
Number of Visits: 3
Length of Participation: 3 months
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02477319
Status: Completed with Results
Description: Part B of the PROSPECT study evaluated the effectiveness of lumacaftor/ivacaftor (Orkambi®) and collected biospecimens and clinical data from people who have two copies of the F508del CFTR mutation both before and after treatment with lumacaftor/ivacaftor.
Age: 12 Years and Older
Mutation: Two Copies F508del
Fev1% Predicted: No FEV1 Limit
Number of Visits: 5
Length of Participation: 1 years
ClinicalTrials.gov link: [None provided]