Cystic Fibrosis Foundation distributed the following clinical trial updates during the month of August. Click the trial title to get more details.
Two alerts were issued on August 11th.
Rare mutation cell collection (RARE)
Status: Enrolling
Description: This study is taking place at multiple care centers across the U.S. Researchers will collect and make available for study cells from people with rare CFTR mutations.
Age: 2 Years and Older
Mutation: No Copies F508del
Fev1% Predicted: No FEV1 Limit
Number of Visits: 1
Length of Participation: 1 days
ClinicalTrials.gov link:https://www.clinicaltrials.gov/ct2/show/NCT03161808
Phase 1/2 study of PTI-801 drug in healthy adults and then in adults with cystic fibrosis
Status: Enrolling
Description: This study is taking place at multiple care centers across the U.S. It will look at the safety and tolerability of the drug PTI-801.
Age: 18 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 40 to 90%
Number of Visits: 8
Length of Participation: 30 days
ClinicalTrials.gov link:https://clinicaltrials.gov/ct2/show/NCT03140527
One alert was issued on August 18th.
Status: Enrolling
Description: This randomized, placebo-controlled study is taking place at multiple care centers across the U.S. This study will look at the safety, effectiveness, and tolerability of the drug tezacaftor/ivacaftor in combination with ivacaftor.
Age: 12 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 25 to 90%
Number of Visits: 5
Length of Participation: 84 days
ClinicalTrials.gov link:https://clinicaltrials.gov/ct2/show/NCT03150719
Four alerts were issued on August 30th.
Phase 3 study of lumacaftor and ivacaftor in children with cystic fibrosis
Status: Completed with results
Description: This study evaluated the safety and effectiveness of lumacaftor and ivacaftor (Orkambi®) combination therapy in children with CF.
Age: 6 Years to 11 Years
Mutation: Two Copies F508del
Fev1% Predicted: 70 to 105%
Number of Visits: 5
Length of Participation: 24 weeks
ClinicalTrials.gov link:https://www.clinicaltrials.gov/ct2/show/NCT02514473
Status: Completed with results
Description: This study evaluated how well people were able to understand and follow the TOBI Podhaler® instructions for use to achieve appropriate dosing.
Age: 6 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 25% or greater
Number of Visits: 2
Length of Participation: 1 months
ClinicalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT02178540
Phase 3 study of inhaled mannitol in adults with cystic fibrosis
Status: Completed with results
Description: This study evaluated the safety and effectiveness of the inhaled drug, Bronchitol® (mannitol).
Age: 18 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 40 to 90%
Number of Visits: 5
Length of Participation: 6 months
ClinicalTrials.gov link:https://www.clinicaltrials.gov/ct2/show/NCT02134353
Home Monitoring of Lung Function
Status: Completed with results
Description: This study evaluated whether at-home monitoring of lung function and symptoms could improve lung function after 12 months by providing earlier detection and subsequent treatment of exacerbations.
Age: 14 Years and Older
Mutation: No Mutation Requirement
Fev1% Predicted: 26% or greater
Number of Visits: 7
Length of Participation: 1 years
ClinicalTrials.gov link:https://www.clinicaltrials.gov/ct2/show/NCT01104402