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Clinical Trial Alerts – May 2020

The following clinical trial alerts were issued by Cystic Fibrosis Foundation in May 2020.

May 4, 2020

A study to evaluate tezacaftor/ivacaftor in adults with cystic fibrosis and two copies of the F508del mutation

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

SIMPLIFY: Study to evaluate stopping inhaled hypertonic saline or dornase alfa in people with CF who are taking the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor

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


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