The following clinical trial alerts were issued by Cystic Fibrosis Foundation in May 2020.
May 4, 2020
Status: Completed with results
Description: This study evaluated the safety, effectiveness, and tolerability of the drug tezacaftor/ivacaftor (Symdeko®). This study was for people with CF ages 12 and older with two copies of the F508del CFTR mutation who had been taken off lumacaftor/ivacaftor (Orkambi®) due to respiratory side effects.
Age: 12 Years and Older
Mutation: Two Copies F508del
Fev1% Predicted: 25 to 90%
Number of Visits: 5
Length of Participation: 84 days
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03150719
AeroVanc for the treatment of MRSA in people with CF
Status: Completed with results
Description: This study evaluated the safety and effectiveness of AeroVanc in treating persistent MRSA lung infections in people with cystic fibrosis.
Age: 12 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 30 to 100%
Number of Visits: 9
Length of Participation: 16 weeks
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT01746095
May 13, 2020
Status: Enroling
Description: This study will test the effects and safety of stopping inhaled hypertonic saline or dornase alfa (Pulmozyme®) in teens and adults with CF who are also taking the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor (Trikafta®). Trikafta® is intended to help CFTR function closer to normal, resulting in better clearance of mucus from the lungs. Inhaled hypertonic saline and dornase alfa are intended to thin airway surface liquid and improve clearance of mucus from the lungs. They are considered to be relatively burdensome therapies, so this study will look at the impact of stopping them in people who are also taking Trikafta®.
Age: 12 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 60% or greater
Number of Visits: 4
Length of Participation: 10 weeks
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04378153