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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Pathological Conditions, Anatomical
Polyps
Respiratory Tract Diseases
Respiratory Tract Infections
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014