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)

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01198912
First received: September 8, 2010
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Chronic Rhinosinusitis
Nasal Polyps
Drug: placebo
Drug: doxycycline 100 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Endoscopic evaluation of quality and speed of wound healing [ Time Frame: at 3 months after first drug intake ] [ Designated as safety issue: No ]
  • Recurrence of nasal polyps [ Time Frame: at 3 months after first drug intake ] [ Designated as safety issue: No ]
  • Recurrence of nasal polyps [ Time Frame: at 6 months after first drug intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nasal and exhaled NO [ Time Frame: at 3 months after first drug intake ] [ Designated as safety issue: No ]
  • nasal and exhaled NO [ Time Frame: at 6 months after first drug intake ] [ Designated as safety issue: No ]
  • subjective assessment of the wound healing [ Time Frame: at 3 months after first drug intake ] [ Designated as safety issue: No ]
  • subjective assessment of the wound healing [ Time Frame: at 6 months after first drug intake ] [ Designated as safety issue: No ]
  • chronic rhinosinusitis symptoms by the patients [ Time Frame: at 3 months after first drug intake ] [ Designated as safety issue: No ]
  • chronic rhinosinusitis symptoms by the patients [ Time Frame: at 6 months after first drug intake ] [ Designated as safety issue: No ]
  • Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire [ Time Frame: at 3 months after first drug intake ] [ Designated as safety issue: No ]
  • Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire [ Time Frame: at 6 months after first drug intake ] [ Designated as safety issue: No ]
  • inflammatory mediators in nasal fluid as well as in serum [ Time Frame: at 3 months after first drug intake ] [ Designated as safety issue: No ]
  • inflammatory mediators in nasal fluid as well as in serum [ Time Frame: at 6 months after first drug intake ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
during 56 days
Experimental: doxycycline 100 mg Drug: doxycycline 100 mg
during 56 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198912

Contacts
Contact: Thibaut Van Zele, MD thibaut.vanzele@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium
Principal Investigator: Claus Bachert, MD, PhD         
Principal Investigator: Thibaut Van Zele, MD         
Germany
Univ.-HNO-Klinik, St. Elisabeth Hospital Not yet recruiting
Bochum, Germany
Principal Investigator: Jan Thomas, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Claus Bachert, MD, PhD University Hospital Ghent, Belgium
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01198912     History of Changes
Other Study ID Numbers: 2010/384
Study First Received: September 8, 2010
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:
rhinosinusitis
doxycycline
Chronic rhinosinusitis with or without nasal polyps

Additional relevant MeSH terms:
Nasal Polyps
Polyps
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Respiratory Tract Infections
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 17, 2014