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”

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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study

Study Primary Completion Date: June 2006

Intervention(s) in this Clinical Trial

• Drug: Zithromax™ (azithromycin) 500mg tablets
• Procedure: Endoscopic Sinus Surgery
• Procedure: Blood sampling for hematology
• Procedure: Blood sampling for plasma chemistry profile
• Procedure: Serum pregnancy test (for women of child-bearing potential)

Primary Measures

• 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 Measures

• To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00232154

Study ID Number: A0661151

ClinicalTrials.gov Identifier: NCT00232154

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.