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NCT02480270 · ClinicalTrials.gov registry record
Outpatient Antibiotic Treatment for a Cystic Fibrosis Pulmonary Exacerbation
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 32
- Enrollment target
NCT02480270: Completed study, sponsored by University of Colorado, Denver.
NCT02480270 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02480270 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study Summary
This study plans to learn more about the effect of oral antibiotics for an outpatient pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung function, airway inflammation and quality of life. In this study subjects will perform pulmonary function tests, provide a sputum sample and complete a questionnaire at two separate clinic visits. If a subject is unable to cough up sputum in clinic he or she will be asked to breathe in a salt water solution to help cough up sputum. The first sputum sample will be obtained at the first visit (within 48 hours of starting antibiotics). Pulmonary function testing and the questionnaire will also be completed at this time. Subjects will complete a two week course of oral antibiotics at home. During these two weeks subjects will be asked to write down the times antibiotics are taken and airway clearance (vest treatment) is performed. Within one week of completing the antibiotic course subjects will return to clinic for a second visit. At that time a sputum sample will be obtained again and if subjects are unable to cough up sputum they will again be asked to breathe in salt water solution to help cough up sputum. Pulmonary function testing and the questionnaire will also be completed at this second visit. Sputum samples will be tested for infections with bacteria and viruses. Sputum samples will also be used to measure markers of airway inflammation (swelling). The investigators hypothesize that the use of two weeks of oral antibiotics for the treatment of a pulmonary exacerbation will result in a decrease in the amount of bacteria measured in sputum. Additionally the investigators hypothesize that treatment with antibiotics will lead to an improvement in lung function, a decrease in airway inflammation and an improvement in quality of life measurements.
Primary Outcome
Quantitative measurements of the primary CF pathogen will be obtained on sputum culture at visits 1 and 2. The change in colony count (measured on the log scale) will be used as the primary outcome.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-08 |
| Est. Completion | 2017-01-04 |
What the finished NCT02480270 record still lists
NCT02480270 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02480270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02480270 about?
NCT02480270 is a clinical study titled "Outpatient Antibiotic Treatment for a Cystic Fibrosis Pulmonary Exacerbation". This study plans to learn more about the effect of oral antibiotics for an outpatient pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung function, airway inflammation and quality of life. In this study subjects will perform pulmonary function tests, provide a s...
What is the current status of trial NCT02480270?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2014-08. Estimated completion is 2017-01-04.
Who is sponsoring clinical trial NCT02480270?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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