Cystic Fibrosis Foundation issued the following clinical trial alerts in November.
November 4, 2020
Status: Enrolling
Description: This study will look at the safety and tolerability of inhaled AP-PA02, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa to find the best dose.
Age: 18 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 60% or greater
Number of Visits: 10
Length of Participation: 31 days
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04596319
Status: Enrolling
Description: This study will look at the safety and tolerability of inhaled AP-PA02, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa to find the best dose.
Age: 18 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 60% or greater
Number of Visits: 8
Length of Participation: 29 days
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04596319
November 5, 2020
Status: Enrolling
Description: This observational study will measure the effects of the triple-combination therapy, elexacaftor/tezacaftor/ivacaftor, in children with CF. These drugs are intended to help CFTR protein function closer to normal. This study will look at how treatment with the triple-combination therapy affects children with CF across many different aspects of the disease.
Age: 6 Years to 11 Years
Mutation: Two Copies F508del or One Copy F508del
Fev1% Predicted: No FEV1 Limit
Number of Visits: 6
Length of Participation: 2 years
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04613128
November 16, 2020
Status: Enrolling
Description: This study will look at the safety and effectiveness of the triple-combination therapy, elexacaftor/tezacaftor/ivacaftor (Trikafta®), in children ages 2-5 years old with CF. These drugs are intended to help CFTR protein function closer to normal.
Age: 2 Years to 5 Years
Mutation: Two Copies F508del or One Copy F508del
Fev1% Predicted: No FEV1 Limit
Number of Visits: 5
Length of Participation: 53 days
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04537793