CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 267 enrolled
Drug / intervention
Home lung function and symptom monitoringdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01104402
NCT01104402N/ACompleted

Early Intervention in Cystic Fibrosis Exacerbation

Johns Hopkins University·interventional·Posted Apr 15, 2010·Updated Oct 23, 2017

In Brief

A clinical study evaluating Home lung function and symptom monitoring for Cystic Fibrosis. Completed, enrolled 267 participants across 3 sites.

Detailed Summary

Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease. Most exacerbations are not treated until they cause increased symptoms, and patients seek medical attention. This proposal details a study of home lung function and symptom monitoring. Subjects will be randomly assigned to one of two groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard care. The home monitoring data will be transmitted electronically to the study center. If spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary exacerbation will be initiated. It is anticipated that use of home monitoring will lead to earlier, more reliable recognition and treatment of exacerbations, which will translate into better lung health.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2010
Enrollment StartOct 1, 2011
Primary CompletionAug 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.2 years ago

Interventions

Home lung function and symptom monitoringdevice

subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device.