Clinical trial NCT01198912: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Rhinosinusitis
Nasal Polyps
Keywords: rhinosinusitis
doxycycline
Chronic rhinosinusitis with or without nasal polyps
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.


Eligibility criteria: 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

Primary outcomes:
measure: Endoscopic evaluation of quality and speed of wound healing
timeFrame: at 3 months after first drug intake
measure: Recurrence of nasal polyps
timeFrame: at 3 months after first drug intake
measure: Recurrence of nasal polyps
timeFrame: at 6 months after first drug intake
Secondary outcomes:
measure: nasal and exhaled NO
timeFrame: at 3 months after first drug intake
measure: nasal and exhaled NO
timeFrame: at 6 months after first drug intake
measure: subjective assessment of the wound healing
timeFrame: at 3 months after first drug intake
measure: subjective assessment of the wound healing
timeFrame: at 6 months after first drug intake
measure: chronic rhinosinusitis symptoms by the patients
timeFrame: at 3 months after first drug intake
measure: chronic rhinosinusitis symptoms by the patients
timeFrame: at 6 months after first drug intake
measure: Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
timeFrame: at 3 months after first drug intake
measure: Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
timeFrame: at 6 months after first drug intake
measure: inflammatory mediators in nasal fluid as well as in serum
timeFrame: at 3 months after first drug intake
measure: inflammatory mediators in nasal fluid as well as in serum
timeFrame: at 6 months after first drug intake
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Bochum
country: Germany
facility: Univ.-HNO-Klinik, St. Elisabeth Hospital
Study officials:
affiliation: University Hospital Ghent, Belgium
name: Claus Bachert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: