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

Condition(s) targeted: Chronic Rhinosinusitis; Nasal Polyps

Intervention: placebo (Drug); doxycycline 100 mg (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital, Ghent

Official(s) and/or principal investigator(s):
Claus Bachert, MD, PhD, Principal Investigator, Affiliation: University Hospital Ghent, Belgium

Overall contact:
Thibaut Van Zele, MD, Email: thibaut.vanzele@ugent.be

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.

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Endoscopic evaluation of quality and speed of wound healing

Recurrence of nasal polyps

Recurrence of nasal polyps

Secondary outcome:

nasal and exhaled NO

nasal and exhaled NO

subjective assessment of the wound healing

subjective assessment of the wound healing

chronic rhinosinusitis symptoms by the patients

chronic rhinosinusitis symptoms by the patients

Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire

Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire

inflammatory mediators in nasal fluid as well as in serum

inflammatory mediators in nasal fluid as well as in serum

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Thibaut Van Zele, MD, Email: thibaut.vanzele@ugent.be

University Hospital Ghent, Ghent, Belgium; Recruiting
Claus Bachert, MD, PhD, Principal Investigator
Thibaut Van Zele, MD, Principal Investigator

Univ.-HNO-Klinik, St. Elisabeth Hospital, Bochum, Germany; Not yet recruiting
Jan Thomas, MD, Principal Investigator

website University Hospital Ghent, Belgium

Starting date: November 2010
Last updated: February 1, 2013