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Restore CFTR Protein Completed with Results
Vertex 770 - a phase 2 trial evaluating the effect of VX- 770 on Lung Clearance Index (Vertex VX10-770-106)
This was a randomized crossover study to evaluate the effect of VX 770 (ivacaftor) on the lung clearance index in people with CF and good lung function (FEV1 percent predicted of >90%). Study participants were randomly assigned to the placebo or ivacaftor (taken orally two times a day for 28 days) and then to "crossover" to whichever study drug they had not taken originally. Lung clearance index is a measurement of lung function.
Eligibility
See other primary eligibility criteria for more information.
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Age:
6 Years and Older -
Mutation(s):
One Copy F508del or No Copies F508del -
FEV1% Predicted:
90% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
To be included in this study patients must have the G551D-CFTR mutation in at least 1 allele (any known or unknown mutations allowed in second allele).
Study Results
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What We Learned:
Study results show that ivacaftor was associated with a significant improvement in lung clearance index (LCI) compared to placebo. Additionally, adverse events were similar between treatment groups.
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Primary Findings:
Effectiveness:
This multi-center, multi-national study was conducted between February 2011 and November 2011. A total of 20 participants were enrolled and 17 completed treatment. The primary outcome measure was change from baseline in lung clearance index (LCI) as measured using multiple-breath washout. Treatment with ivacaftor led to significant improvements compared with placebo (difference between groups in the average mean change from baseline at days 15 and 29 was –2.16, p<0·0001).
Additional measures of lung function also improved significantly with ivacaftor treatment compared with placebo (FEV1 % predicted and FEF25%–75% predicted).
Safety:
Adverse events were similar between treatment groups.
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Citation:
JAMA ;DOI 10.1016/S2213-2600(13)70182-6
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
Yes -
Length of Participation:
19 weeks -
Number of Study Visits:
8
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Vertex -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years and Older -
Mutation(s):
One Copy F508del or No Copies F508del -
FEV1% Predicted:
90% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
To be included in this study patients must have the G551D-CFTR mutation in at least 1 allele (any known or unknown mutations allowed in second allele).
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