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NCT02781610 · ClinicalTrials.gov registry record · Phase 4
Standardized Treatment of Pulmonary Exacerbations II
A Phase 4 study, sponsored by Chris Goss.
- Completed
- Registry status
- Phase 4
- Development phase
- 982
- Enrollment target
NCT02781610: Completed Phase 4 study, sponsored by Chris Goss.
NCT02781610 is a Phase 4 study that has completed, run by Chris Goss. The registered enrollment target is 982 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02781610, a Phase 4 study, has completed, sponsored by Chris Goss.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 982 participants
- Enrollment target
Study Summary
Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases. These pulmonary exacerbations are treated with varying antibiotics for varying time periods based on needs determined by individual patients, their families, and the health care providers. Cystic fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also identified key questions for which additional studies were needed. A strong desire among clinicians to reduce treatment durations (and reduce cost, inconvenience, and potential toxicities) is in conflict with belief that patients not responding robustly to treatment might benefit from extending treatment. This randomized, controlled, open-label study is designed to evaluate the efficacy and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adult patients with CF.
Primary Outcome
Absolute change in FEV1 % predicted from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).
Interventions
- DRUG Standard of care IV antibiotic(s)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 982 participants |
| Start Date | 2016-06 |
| Est. Completion | 2020-03-06 |
| Phase | Phase 4 |
What the finished NCT02781610 record still lists
NCT02781610 is an interventional study that assigns participants to a tested intervention. The registered 982 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 1 intervention - of which Standard of care IV antibiotic(s) is the first listed.
NCT02781610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02781610 about?
NCT02781610 is a clinical study titled "Standardized Treatment of Pulmonary Exacerbations II". Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases. These pulmonary exacerbations are treated with varying antibiotics for varying time periods based on needs determined by individual patie...
What is the current status of trial NCT02781610?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 982 participants. The study started on 2016-06. Estimated completion is 2020-03-06.
What interventions are being tested in trial NCT02781610?
The interventions under investigation include: Standard of care IV antibiotic(s) (DRUG).
Who is sponsoring clinical trial NCT02781610?
This trial is sponsored by Chris Goss, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02781610's enrollment target sits among peer trials
982 75th of 2000 higher than 1,926 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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