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NCT01104402 · ClinicalTrials.gov registry record · NA

Early Intervention in Cystic Fibrosis Exacerbation

A NA study of Cystic Fibrosis, sponsored by Johns Hopkins University.

Completed
Registry status
NA
Development phase
267
Enrollment target
3
Study locations

NCT01104402 is a NA study of Cystic Fibrosis that has completed, run by Johns Hopkins University. The registered enrollment target is 267 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (50% higher). The trial reports 3 study locations across 2 states.

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The verdict

NCT01104402, a NA study of Cystic Fibrosis, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
NA
Development phase
267 participants
Enrollment target
3
Study locations

Study 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 Studied

Interventions

  • DEVICE Home lung function and symptom monitoring

Study Locations (3)

Washington

  • University of Washington - Seattle
  • Seattle Children's Hospital - Seattle

Maryland

  • Johns Hopkins University CF Clinic - Baltimore

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2011-10
Est. Completion 2015-09
Phase NA

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT01104402

The ClinicalTrials.gov registry entry for NCT01104402 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (50% higher). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Home lung function and symptom monitoring is the first listed.

NCT01104402 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Washington, Maryland.

Frequently Asked Questions

What is clinical trial NCT01104402 about?

NCT01104402 is a clinical study titled "Early Intervention in Cystic Fibrosis Exacerbation". 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 an...

What is the current status of trial NCT01104402?

This trial is currently completed. It is a NA study. The enrollment target is 267 participants. The study started on 2011-10. Estimated completion is 2015-09.

What conditions does trial NCT01104402 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT01104402?

The interventions under investigation include: Home lung function and symptom monitoring (DEVICE).

Who is sponsoring clinical trial NCT01104402?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01104402 being conducted?

This trial has 3 study locations across Maryland, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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