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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: Completed NA study of Cystic Fibrosis, sponsored by Johns Hopkins University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome variable is FEV1 which will be obtained at quarterly study visits. The primary analysis will use a linear mixed effects model incorporating all FEV1 measurements to estimate the 52-week change in FEV1
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
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT01104402 record still lists
NCT01104402 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (50% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01104402's enrollment target sits among peer trials
267 25th of 169 higher than 145 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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