NCT01198912

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 22, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2017

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

4.8 years

First QC Date

September 8, 2010

Last Update Submit

June 14, 2018

Conditions

Chronic RhinosinusitisNasal Polyps

Keywords

rhinosinusitisdoxycyclineChronic rhinosinusitis with or without nasal polyps

Outcome Measures

Primary Outcomes (3)

  • Endoscopic evaluation of quality and speed of wound healing

    at 3 months after first drug intake

  • Recurrence of nasal polyps

    at 3 months after first drug intake

  • Recurrence of nasal polyps

    at 6 months after first drug intake

Secondary Outcomes (10)

  • nasal and exhaled NO

    at 3 months after first drug intake

  • nasal and exhaled NO

    at 6 months after first drug intake

  • subjective assessment of the wound healing

    at 3 months after first drug intake

  • subjective assessment of the wound healing

    at 6 months after first drug intake

  • chronic rhinosinusitis symptoms by the patients

    at 3 months after first drug intake

  • +5 more secondary outcomes

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: placebo

doxycycline 100 mg

EXPERIMENTAL
Drug: doxycycline 100 mg

Interventions

placeboDRUG

during 56 days

placebo
doxycycline 100 mgDRUG

during 56 days

doxycycline 100 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Ghent

Ghent, Belgium

Location

Univ.-HNO-Klinik, St. Elisabeth Hospital

Bochum, Germany

Location

Related Links

MeSH Terms

Conditions

Nasal PolypsRhinosinusitis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsRhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Claus Bachert, MD, PhD

    University Hospital Ghent, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 10, 2010

Study Start

November 22, 2011

Primary Completion

September 6, 2016

Study Completion

February 6, 2017

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

DE(1)BE(1)