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Behavioral Completed with Results
Study of adherence to lumacaftor/ivacaftor using a smart pill bottle device (Vertex VX-809-114)
This study evaluated the impact of a smart pill bottle device on adherence to lumacaftor/ivacaftor (Orkambi®). This study was for people with CF who were not currently being treated with lumacaftor/ivacaftor (Orkambi®) prior to enrolling in the study.
All study participants, who were taking lumacaftor (400mg once a day) plus ivacaftor (250mg twice a day), used a smart pill bottle device that electronically tracked their medication use. Participants were randomly assigned to one of two groups. Participants in the test group received alerts and feedback from the smart bottle, while participants in the control group did not receive alerts or feedback. Participants used the smart pill bottles for up to 35 weeks.
Eligibility
See other primary eligibility criteria for more information.
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Age:
16 Years and Older -
Mutation(s):
Two Copies F508del -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must be homozygous for the F508del-CFTR mutation.
Study Results
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What We Learned:
This study found that participants who received alerts and feedback from a smart pill bottle device were 92% adherent over a 35 week period, while participants who were not receiving alerts or feedback were 86% adherent.
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Primary Findings:
Effectiveness:
Safety:
This study was conducted between October 2016 and August 2017. This study enrolled 24 participants (test group N=15, control group N=9).
The primary objective of this study was to determine the percentage of participants that were adherent to taking their lumacaftor/ivacaftor from the beginning of the study to week 35. This study found that the group that received alerts and feedback took 92% of the prescribed doses, and the group that did not receive alerts took 86% of the prescribed doses.
In the group that received alerts and feedback, 86% of participants were at least 90% adherent during the study. In the group that did not receive alerts, only 33% of participants were at least 90% adherent during the study.
Lumacaftor/ivacaftor was well-tolerated, as seen in previous trials.
These results have been provided by Clinicaltrials.gov and have not been peer-reviewed.
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Citation:
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
48 weeks -
Number of Study Visits:
7
Additional Information
-
Phase: ?more info
Phase Four/Post-Approval -
Study Sponsor: ?more info
Vertex -
Study Drugs:
N/A
Eligibility
See other primary eligibility criteria for more information.
-
Age:
16 Years and Older -
Mutation(s):
Two Copies F508del -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must be homozygous for the F508del-CFTR mutation.
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