Clinical trial NCT00232154: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sinusitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Known or suspected hypersensitivity or intolerance to any macrolide-like compound, including erythromycin, clarithromycin, azithromycin or telithromycin.

Primary outcomes:
measure: 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:
measure: To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Hoover
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Hoover
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Elgin
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Elgin
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Maywood
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Carrollton
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: La Grange
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: