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:
University Hospital, Ghent
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
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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:
MedlinePlus related topics:
Endoscopy
Drug Information available for:
Doxycycline
Doxycycline monohydrate
Doxycycline Hyclate
Doxycycline calcium
U.S. FDA Resources
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 :
- 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
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 May 16, 2013