A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up To
An Open-Label Study Of Azithromycin Pharmacokinetics In Sinus Mucosal Tissue And Plasma In Subjects With Chronic Rhinosinusitis Following A Single 2g Dose Of Azithromycin Extended Release For Oral Suspension Or Azithromycin 500mg Tablet Formulation Once Daily For A Maximum Of Three Days
1 other identifier
interventional
72
1 country
18
Brief Summary
To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg tablets for up to 3 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2005
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedApril 21, 2011
April 1, 2011
7 months
September 30, 2005
April 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To characterize the pharmacokinetics of azithromycin in sinus mucosal tissue and plasma in adult subjects after treatment with a single 2 g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500 mg tablet
Secondary Outcomes (1)
To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects considered by the Principal Investigator as an appropriate candidate for endoscopic sinus surgery, e.g., for the removal of the thickened and diseased mucosal tissue that blocks the ostiomeatal complex (OMC).
You may not qualify if:
- Known or suspected hypersensitivity or intolerance to any macrolide-like compound, including erythromycin, clarithromycin, azithromycin or telithromycin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (18)
Pfizer Investigational Site
Alabaster, Alabama, 35007, United States
Pfizer Investigational Site
Birmingham, Alabama, 35209, United States
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Pfizer Investigational Site
Birmingham, Alabama, 35242, United States
Pfizer Investigational Site
Hoover, Alabama, 35216, United States
Pfizer Investigational Site
Hoover, Alabama, 35244, United States
Pfizer Investigational Site
Fresno, California, 93720, United States
Pfizer Investigational Site
Jacksonville, Florida, 32216, United States
Pfizer Investigational Site
Miami, Florida, 33136-1002, United States
Pfizer Investigational Site
Augusta, Georgia, 30912, United States
Pfizer Investigational Site
Elgin, Illinois, 60120, United States
Pfizer Investigational Site
Elgin, Illinois, 60123, United States
Pfizer Investigational Site
Maywood, Illinois, 60153, United States
Pfizer Investigational Site
Carrollton, Kentucky, 41008, United States
Pfizer Investigational Site
La Grange, Kentucky, 40031, United States
Pfizer Investigational Site
Louisville, Kentucky, 40207, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
November 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
April 21, 2011
Record last verified: 2011-04