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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| doxycycline 100 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | during 56 days |
| |
| doxycycline 100 mg |
| 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 |
| 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 |
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Inclusion Criteria:
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 :
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| Name | Affiliation | Role |
|---|---|---|
| Claus Bachert, MD, PhD | University Hospital Ghent, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | Belgium | ||||
| Univ.-HNO-Klinik, St. Elisabeth Hospital |
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| Label | URL |
|---|---|
| website University Hospital Ghent, Belgium | View source |
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| Drug |
during 56 days |
|
| 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 |
| Bochum |
| Germany |
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012220 | Rhinitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
| D010254 | Paranasal Sinus Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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