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Early Intervention in Cystic Fibrosis Exacerbation
NCT01104402 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01104402
The ClinicalTrials.gov registry entry for NCT01104402 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01104402 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Washington, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01104402?
The interventions under investigation include: Home lung function and symptom monitoring (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01104402?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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