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Early Intervention in Cystic Fibrosis Exacerbation

NCT01104402 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2017-10-23

Study results available
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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.

Conditions

Interventions

DEVICE

Home lung function and symptom monitoring

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

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Noah Lechtzin, MD · Johns Hopkins University

  • Christopher Goss, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-08-31
Completion
2015-09-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01104402 on ClinicalTrials.gov