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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Sinusitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00232154

A0661151

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.