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.
- Conditions
- Chronic rhinosinusitis
- Registration Number
- EUCTR2009-017997-19-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
- Subjects must be at least 18 years of age, of either sex and any race.
Subjects must have a diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines research. Chronic rhinosinusitis with or without nasal polyps is defined as: presence of two or more symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip): ± facial pain/pressure; ± reduction or loss of smell; for >12 weeks. The differentiation between CRS and NP must be based on outpatient endoscopy. Once surgery has altered the anatomy of the lateral wall, the presence of polyps is defined as bilateral pedunculated lesions as opposed to cobblestoned mucosa > 6 months after surgery on endoscopic examination. Any mucosal disease without overt polyps should be regarded as CRS.
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the beneficial effect of oral doxycycline on wound healing after endoscopic sinus surgery in subjects with chronic rhinosinusitis with or without nasal polyps;Secondary Objective: ;Primary end point(s): Clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery
- Secondary Outcome Measures
Name Time Method