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

Phase 2

Completed

• Conditions: Chronic Rhinosinusitis; Nasal Polyps
• Interventions: Drug: placebo; Drug: doxycycline 100 mg

• Registration Number: NCT01198912
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Study Start: 2011-11-22
• Primary Completion: 2016-09-06
• Study Completion: 2017-02-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
doxycycline 100 mg	doxycycline 100 mg	-

Primary Outcome Measures

Name	Time	Method
Endoscopic evaluation of quality and speed of wound healing	at 3 months after first drug intake
Recurrence of nasal polyps	at 6 months after first drug intake

Secondary Outcome Measures

Name	Time	Method
nasal and exhaled NO	at 6 months after first drug intake
inflammatory mediators in nasal fluid as well as in serum	at 6 months after first drug intake
subjective assessment of the wound healing	at 6 months after first drug intake
chronic rhinosinusitis symptoms by the patients	at 6 months after first drug intake
Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire	at 6 months after first drug intake

Trial Locations

Locations (2)

Univ.-HNO-Klinik, St. Elisabeth Hospital; 🇩🇪 Bochum, Germany

University Hospital Ghent; 🇧🇪 Ghent, Belgium