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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)

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ClinicalTrials.gov Identifier: NCT01198912
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Nasal Polyps Drug: placebo Drug: doxycycline 100 mg Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : November 2010
Primary Completion Date : September 2016
Study Completion Date : September 2016

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
during 56 days
Experimental: doxycycline 100 mg Drug: doxycycline 100 mg
during 56 days


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198912


Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Germany
Univ.-HNO-Klinik, St. Elisabeth Hospital
Bochum, Germany
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Claus Bachert, MD, PhD University Hospital Ghent, Belgium
More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01198912     History of Changes
Other Study ID Numbers: 2010/384
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

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

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