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Other Completed with Results
Home Monitoring of Lung Function (eICE-ID-10)
This study evaluated whether at-home monitoring of lung function and symptoms could improve lung function after 12 months by providing earlier detection and treatment of exacerbations. Study participants were randomly assigned to one of two groups: 1) home monitoring, in which spirometry and respiratory symptoms were recorded twice weekly or 2) usual care. For participants in the home monitoring group, the spirometry and symptom information was transmitted by phone modem weekly to the study nurse; if the data indicated a possible pulmonary exacerbation, participants were prescribed treatment. Participants in the usual care group contacted their clinic if they were feeling sick and their physician would determine if treatment was needed.
Eligibility
See other primary eligibility criteria for more information.
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Age:
14 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
26% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible subjects are in a clinically stable state at baseline.
Study Results
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What We Learned:
Study results showed that after 12 months there was no difference in lung function between the home monitoring group when compared to the usual care group.
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Primary Findings:
Effectiveness:
This multi-center study was conducted between October 2011 and July 2015. The study enrolled 267 participants, 135 were randomized to the home monitoring group and 132 to the usual care group. The study was stopped early by the Data Monitoring Committee due to no clear differences being observed between the home monitoring and usual care groups (futility) and lagging enrollment. The primary analysis results showed no difference in lung function (mean change in FEV1 after 52 weeks) in the home monitoring group compared with the usual care group.
No differences between the groups were observed in the change in respiratory symptom scores (neither the CFQ-R or CFRSD questionnaires). Adherence to performing the home monitoring was assessed; only 50% of the home monitoring group participants transmitted data at least once a week during most of their follow-up weeks.
Safety:
A higher rate of hospitalizations for pulmonary exacerbations was observed in the home monitoring group compared to usual care (Rate Ratio=1.45, 95% C.I. = [1.09, 1.93], p=0.01). This higher rate of hospitalization was expected, since the intervention was designed to detect respiratory complications more rapidly than usual care.
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Citation:
Am J Respir Crit Care Med 2017;DOI 10.1164/rccm.201610-2172OC;196(9):1144-1151
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:
1 years -
Number of Study Visits:
7
Additional Information
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Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Goss, Christopher -
Study Drugs:
N/A
Eligibility
See other primary eligibility criteria for more information.
-
Age:
14 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
26% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible subjects are in a clinically stable state at baseline.
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