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NCT02054156 · ClinicalTrials.gov registry record · Phase 3
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
A Phase 3 study of Cystic Fibrosis, sponsored by Bonnie Ramsey.
- Completed
- Registry status
- Phase 3
- Development phase
- 221
- Enrollment target
- 20
- Study locations
NCT02054156 is a Phase 3 study of Cystic Fibrosis that has completed, run by Bonnie Ramsey. The registered enrollment target is 221 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT02054156, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Bonnie Ramsey.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 221 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.
Conditions Studied
Interventions
- DRUG placebo
- DRUG azithromycin
- DRUG Tobramycin solution for inhalation
Study Locations (20)
California
- Childrens Hospital Los Angeles - Los Angeles
- CFF Care Center & Pediatric Program Stanford University - Palo Alto
Florida
- CFF Care Center & Pediatric Program Nemours Children's Clinic - Jacksonville - Jacksonville
- CFF Care Center & Pediatric Program All Children's Hospital - St. Petersburg
Georgia
- CFF Care Center & Pediatric Program Emory University - Atlanta
- CFF Affiliate Program Children's Healthcare of Atlanta - Atlanta
Michigan
- CFF Care Center & Pediatric Program University of Michigan - Ann Arbor
- CFF Care Center & Pediatric Program Children's Hospital of Michigan - Detroit
Alaska
- CFF Affiliate Program Providence Medical Center - Anchorage
Arizona
- CFF Care Center Arizona Health Science Center - Tucson
Arkansas
- CFF Care Center & Pediatric Program Arkansas Children's Hospital - Little Rock
Colorado
- CFF Care Center & Pediatric Program Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2014-06 |
| Est. Completion | 2018-08-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02054156
The ClinicalTrials.gov registry entry for NCT02054156 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 221 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 (24% higher). The listed sponsor is Bonnie Ramsey, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT02054156 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02054156 about?
NCT02054156 is a clinical study titled "OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis". The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of b...
What is the current status of trial NCT02054156?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 221 participants. The study started on 2014-06. Estimated completion is 2018-08-23.
What conditions does trial NCT02054156 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT02054156?
The interventions under investigation include: placebo (DRUG), azithromycin (DRUG), Tobramycin solution for inhalation (DRUG).
Who is sponsoring clinical trial NCT02054156?
This trial is sponsored by Bonnie Ramsey, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02054156 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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