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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 (DOXYPOSTOP)

Primary Purpose

Chronic Rhinosinusitis, Nasal Polyps

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
doxycycline 100 mg
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis focused on measuring rhinosinusitis, doxycycline, Chronic rhinosinusitis with or without nasal polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent
  • Univ.-HNO-Klinik, St. Elisabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

doxycycline 100 mg

Arm Description

Outcomes

Primary Outcome Measures

Endoscopic evaluation of quality and speed of wound healing
Recurrence of nasal polyps
Recurrence of nasal polyps

Secondary Outcome Measures

nasal and exhaled NO
nasal and exhaled NO
subjective assessment of the wound healing
subjective assessment of the wound healing
chronic rhinosinusitis symptoms by the patients
chronic rhinosinusitis symptoms by the patients
Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
inflammatory mediators in nasal fluid as well as in serum
inflammatory mediators in nasal fluid as well as in serum

Full Information

First Posted
September 8, 2010
Last Updated
June 14, 2018
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01198912
Brief 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
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 22, 2011 (Actual)
Primary Completion Date
September 6, 2016 (Actual)
Study Completion Date
February 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis, Nasal Polyps
Keywords
rhinosinusitis, doxycycline, Chronic rhinosinusitis with or without nasal polyps

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
doxycycline 100 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
during 56 days
Intervention Type
Drug
Intervention Name(s)
doxycycline 100 mg
Intervention Description
during 56 days
Primary Outcome Measure Information:
Title
Endoscopic evaluation of quality and speed of wound healing
Time Frame
at 3 months after first drug intake
Title
Recurrence of nasal polyps
Time Frame
at 3 months after first drug intake
Title
Recurrence of nasal polyps
Time Frame
at 6 months after first drug intake
Secondary Outcome Measure Information:
Title
nasal and exhaled NO
Time Frame
at 3 months after first drug intake
Title
nasal and exhaled NO
Time Frame
at 6 months after first drug intake
Title
subjective assessment of the wound healing
Time Frame
at 3 months after first drug intake
Title
subjective assessment of the wound healing
Time Frame
at 6 months after first drug intake
Title
chronic rhinosinusitis symptoms by the patients
Time Frame
at 3 months after first drug intake
Title
chronic rhinosinusitis symptoms by the patients
Time Frame
at 6 months after first drug intake
Title
Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
Time Frame
at 3 months after first drug intake
Title
Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire
Time Frame
at 6 months after first drug intake
Title
inflammatory mediators in nasal fluid as well as in serum
Time Frame
at 3 months after first drug intake
Title
inflammatory mediators in nasal fluid as well as in serum
Time Frame
at 6 months after first drug intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 : 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Bachert, MD, PhD
Organizational Affiliation
University Hospital Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium
Facility Name
Univ.-HNO-Klinik, St. Elisabeth Hospital
City
Bochum
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website University Hospital Ghent, Belgium

Learn more about this trial

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

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