Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial

• Status: Completed
• Trial end date: 2017-02-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. The objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: Doxycycline

Criteria

Inclusion Criteria:

• at least 18 years of age, of either sex and any race

• diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines research

• Subjects should be regularly scheduled for bilateral functional endonasal endoscopic sinus surgery

• Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.

• Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.

• Nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control.

Exclusion Criteria:

• Women must not be pregnant, breast feeding, or premenarcheal.

• Subjects who have required oral corticosteroids within the previous four weeks prior to surgery.

• Subjects who have required nasal corticosteroids within the previous one week prior to surgery.

• Subjects with known allergic reaction on tetracyclines, diabetes (type 1 and 2), renal insufficiency, severe liver disease, systemic diseases affecting the nose (e.g. M. Wegener), prior surgeries of the paranasal sinuses.

• Patients with the following diseases should be excluded :

1. Cystic fibrosis based on positive sweat test or DNA alleles

2. Gross immunodeficiency (congenital or acquired)

3. congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD)

4. Non-invasive fungal balls and invasive fungal disease

5. systemic vasculitis and granulomatous diseases

6. Cocaine abuse

7. Neoplasia