Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

during 56 days

doxycycline 100 mg

Drug

during 56 days

Primary outcomes

  1. Endoscopic evaluation of quality and speed of wound healing

    Time frame: at 3 months after first drug intake

  2. Recurrence of nasal polyps

    Time frame: at 3 months after first drug intake

  3. Recurrence of nasal polyps

    Time frame: at 6 months after first drug intake

Secondary outcomes

  1. nasal and exhaled NO

    Time frame: at 3 months after first drug intake

  2. nasal and exhaled NO

    Time frame: at 6 months after first drug intake

  3. subjective assessment of the wound healing

    Time frame: at 3 months after first drug intake

  4. subjective assessment of the wound healing

    Time frame: at 6 months after first drug intake

  5. chronic rhinosinusitis symptoms by the patients

    Time frame: at 3 months after first drug intake

  6. chronic rhinosinusitis symptoms by the patients

    Time frame: at 6 months after first drug intake

  7. Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire

    Time frame: at 3 months after first drug intake

  8. Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire

    Time frame: at 6 months after first drug intake

  9. inflammatory mediators in nasal fluid as well as in serum

    Time frame: at 3 months after first drug intake

  10. inflammatory mediators in nasal fluid as well as in serum

    Time frame: at 6 months after first drug intake

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study 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.

Acronym: DOXYPOSTOP

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Sep 10, 2010
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.