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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: Completed Phase 3 study of Cystic Fibrosis, sponsored by Bonnie Ramsey.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to a protocol-defined pulmonary exacerbation requiring oral, inhaled, or intravenous antibiotics, using a prespecified definition available in the study protocol.
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 |
What the finished NCT02054156 record still lists
NCT02054156 is an interventional study that assigns participants to a tested intervention. The registered 221 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 (24% higher).
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 names 20 study sites across 16 states, led by 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.
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 NCT02054156's enrollment target sits among peer trials
221 32nd of 169 higher than 138 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.
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