Status:
COMPLETED
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
Lead Sponsor:
University Hospital, Ghent
Conditions:
Chronic Rhinosinusitis
Nasal Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 lo...
Eligibility Criteria
Inclusion
- 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
- 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 :
- Cystic fibrosis based on positive sweat test or DNA alleles
- Gross immunodeficiency (congenital or acquired)
- congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD)
- Non-invasive fungal balls and invasive fungal disease
- systemic vasculitis and granulomatous diseases
- Cocaine abuse
- Neoplasia
Key Trial Info
Start Date :
November 22 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01198912
Start Date
November 22 2011
End Date
February 6 2017
Last Update
June 15 2018
Active Locations (2)
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1
University Hospital Ghent
Ghent, Belgium
2
Univ.-HNO-Klinik, St. Elisabeth Hospital
Bochum, Germany