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Aug

Clinical Trial Alerts – August 2017

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.

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

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

TOBI Podhaler Usability Study

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


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