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

Nasal Polyps Clinical Trial

— DOXYPOSTOP  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198912
• Other study ID #: 2010/384
• Status: Completed
• Phase: Phase 2
• Start date: November 22, 2011
• Est. completion date: February 6, 2017

Study information

• Verified date: June 2018
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 6, 2017
• Est. primary completion date: September 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Nasal Polyps
• Sinusitis

Intervention

Drug:
• placebo
during 56 days
• doxycycline 100 mg
during 56 days

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent
Germany	Univ.-HNO-Klinik, St. Elisabeth Hospital	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic evaluation of quality and speed of wound healing		at 3 months after first drug intake
Primary	Recurrence of nasal polyps		at 3 months after first drug intake
Primary	Recurrence of nasal polyps		at 6 months after first drug intake
Secondary	nasal and exhaled NO		at 3 months after first drug intake
Secondary	nasal and exhaled NO		at 6 months after first drug intake
Secondary	subjective assessment of the wound healing		at 3 months after first drug intake
Secondary	subjective assessment of the wound healing		at 6 months after first drug intake
Secondary	chronic rhinosinusitis symptoms by the patients		at 3 months after first drug intake
Secondary	chronic rhinosinusitis symptoms by the patients		at 6 months after first drug intake
Secondary	Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire		at 3 months after first drug intake
Secondary	Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire		at 6 months after first drug intake
Secondary	inflammatory mediators in nasal fluid as well as in serum		at 3 months after first drug intake
Secondary	inflammatory mediators in nasal fluid as well as in serum		at 6 months after first drug intake

External Links

•   website University Hospital Ghent, Belgium