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 Overview
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Brief Summary
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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
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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
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Chronic Rhinosinusitis, Nasal Polyps

Intervention / Treatment
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* Drug: placebo
* Drug: doxycycline 100 mg


Participation Criteria
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Eligibility Criteria
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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 : 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo<br>* during 56 days<br>|
| Experimental: doxycycline 100 mg<br> | Drug: doxycycline 100 mg<br>* during 56 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic evaluation of quality and speed of wound healing |  | at 3 months after first drug intake | 
| Recurrence of nasal polyps |  | at 3 months after first drug intake | 
| Recurrence of nasal polyps |  | at 6 months after first drug intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nasal and exhaled NO |  | at 3 months after first drug intake | 
| nasal and exhaled NO |  | at 6 months after first drug intake | 
| subjective assessment of the wound healing |  | at 3 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 3 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 3 months after first drug intake | 
| Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire |  | at 6 months after first drug intake | 
| inflammatory mediators in nasal fluid as well as in serum |  | at 3 months after first drug intake | 
| inflammatory mediators in nasal fluid as well as in serum |  | at 6 months after first drug intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhinosinusitis, doxycycline, Chronic rhinosinusitis with or without nasal polyps