A Two-Part Multicenter Prospective Longitudinal Study of CFTR-dependent Disease Profiling in Cystic Fibrosis (PROSPECT) (PROSPECT)
|ClinicalTrials.gov Identifier: NCT02477319|
Recruitment Status : Completed
First Posted : June 22, 2015
Results First Posted : May 20, 2020
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment|
|Cystic Fibrosis||Other: Observational|
|Study Type :||Observational|
|Actual Enrollment :||452 participants|
|Official Title:||A Two-Part Multicenter Prospective Longitudinal Study of CFTR-dependent Disease Profiling in Cystic Fibrosis (PROSPECT)|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||April 25, 2018|
|Actual Study Completion Date :||July 27, 2018|
CF patients who are homozygous for the F508del
- Sweat Chloride by Cohort (Part A Only) [ Time Frame: For cohort 1, sweat chloride at Day 0 is time frame. For cohorts 2-3, sweat chloride averaged across all 3 visits at days 0, 14 and 90 is time frame. ]
This is the primary endpoint for Part A per the PROSPECT protocol. Mean sweat chloride was not reported for Part B, as it is not a relevant statistic.
For cohort 1, sweat chloride is from day 0 only. For cohorts 2-3, sweat chloride was averaged from days 0, 14, 90 via a random intercept longitudinal model.
- 6 Month Change in FEV1 Percent Predicted (Part B Only) [ Time Frame: Baseline and 6 months ]This is the primary endpoint for Part B per the PROSPECT protocol. Change in FEV1 Percent Predicted is only relevant for Part B as it captures changes in lung function post-initiation of Ivacaftor/Lumacaftor.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477319