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Clinical Trial Alerts – July 2018

Cystic Fibrosis Foundation distributed the following clinical trial updates during the month of July. Click the trial title to get more details.

The following alert was issued on July 11:

SHIP CT: Study of hypertonic saline in preschoolers

Status: Enrollment

Description: This study is taking place in Europe, Australia and the U.S. It will look at the safety and effectiveness of hypertonic saline compared to isotonic saline (normal saline) in children with CF.

Age: 3 Years to 5 Years

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 6

Length of Participation: 54 weeks

ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT02950883

The following alerts were issued on July 20:

Phase 2 study of VX-440 combination drug in people with cystic fibrosis

Status: Completed with results

Description: This study evaluated the safety and tolerability of the drug VX-440 in combination with ivacaftor and tezacaftor (VX-661) in people who either have two copies of the F508del CFTR mutation or have one copy of F508del and one copy of a minimal function CFTR mutation.

Age: 12 Years and Older

Mutation: Two Copies F508del or One Copy F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 11

Length of Participation: 57 days

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02951182

Phase 2 study of VX-152 combination drug in people with cystic fibrosis

Status: Completed with results

Description: This study evaluated the safety and tolerability of the drug VX-152 in combination with ivacaftor and tezacaftor (VX-661) in people who either have two copies of the F508del CFTR mutation or have one copy of F508del and one copy of a minimal function CFTR mutation.

Age: 18 Years and Older

Mutation: Two Copies F508del or One Copy F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 10

Length of Participation: 16 weeks

ClinicalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT02951195

Clearing Lungs With ENAC Inhibition in Cystic Fibrosis (CLEAN-CF)

Status: Completed with results

Description: This study evaluated the drug P-1037 and its effectiveness in combination with the drug hypertonic saline in people with CF. There was no restriction based on CFTR mutation.

Age: 12 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40 to 90%

Number of Visits: 4

Length of Participation: 5 weeks

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02343445

Phase 3 study of Ataluren in people with CF who have a nonsense mutation and are not taking aminoglycosides

Status: Completed with results

Description: This study evaluated the safety and effectiveness of the drug ataluren (PTC124®) compared with placebo. This study was for people with CF who have a nonsense mutation and were not receiving chronic inhaled aminoglycosides.

Age: 6 Years and Older

Mutation: One Copy F508del or No Copies F508del

Fev1% Predicted: 60 to 90%

Number of Visits: 10

Length of Participation: 56 weeks

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/results/NCT02139306

Observational Study in Children 6 Years and Up who have the R117H or other non-G551D gating mutation

Status: Completed with results

Description: These observational cohorts were a part of the expansion of the GOAL-e2 Study (GOAL-OB-11 Expanded and Extended). In these cohorts, data were collected from people with CF who have the R117H and other non-G551D gating CFTR mutations and had never takenivacaftor (Kalydeco®).

Age: 6 Years and Older

Mutation: One Copy F508del or No Copies F508del

Fev1% Predicted: No FEV1 Limit

Number of Visits: 5

Length of Participation: 6 months

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT01521338

AquADEKs-2: Effects of an antioxidant-enriched multivitamin on inflammation and oxidative stress in people with CF

Status: Completed with results

Description: This study evaluated the effects of an antioxidant-enriched multivitamin supplement on inflammation. This study was for people with CF who are pancreatic insufficient.

Age: 10 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40 to 100%

Number of Visits: 4

Length of Participation: 20 weeks

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT01859390


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