Clinical Trial Alerts – October 2022

Cystic Fibrosis Foundation issued the following clinical trial alerts in October:

October 3, 2022

Study to evaluate the standardizing of treatment for pulmonary exacerbations in children and adults with CF ages 6 and older.

Status: Enrolling

Description: This study will look at pulmonary exacerbations, which are a worsening of respiratory symptoms, in people with CF who need to be treated with intravenous (IV) antibiotics. It will compare treatment with one antibiotic (a beta-lactam) to treatment with two antibiotics (tobramycin and a beta-lactam) to learn whether there is a difference in lung function and symptom improvement between the two groups. This study is for people ages 6 and older.

Age: 6 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 3

Length of Participation: 48 days

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05548283

October 27, 2022

Study of galicaftor/navocaftor/ABBV-576 combination therapy in adults with cystic fibrosis who have at least one F508del mutation and are on stable elexacaftor/tezacaftor/ivacaftor (Trikafta) treatment.

Status: Enrolling

Description: This study will look at the safety and effectiveness of the galicaftor/navocaftor/ABBV-576 combination therapy, a combination of CFTR modulators intended to help CFTR protein function closer to normal. This study is for adults with cystic fibrosis who have at least one F508del 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: 3 months

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04853368