NCT01253577

Brief Summary

The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

11 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

Study Start

First participant enrolled

December 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

April 13, 2015

Completed
Last Updated

June 22, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

December 2, 2010

Results QC Date

December 11, 2012

Last Update Submit

May 26, 2015

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (2)

  • Percentage of Sinuses Requiring Post-operative Intervention

    Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.

    30-days

  • Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure

    clinically significant IOP elevation is a change from baseline of \>10 mm Hg on sinus side with drug-coated implant but not on side with control implant

    90 days

Secondary Outcomes (1)

  • Percentage of Sinuses That Developed Frank Polyposis

    30 days

Study Arms (2)

Drug Coated

ACTIVE COMPARATOR

Sinus stent coated with steroid

Device: Sinus Stent with drug coating

Non coated

PLACEBO COMPARATOR

Sinus stent without drug coating

Device: Non Coated Sinus Stent

Interventions

Sinus Stent with drug coatingDEVICE

Sinus stent coated with 370 ug of the corticosteroid mometasone furoate

Drug Coated
Non Coated Sinus StentDEVICE

Sinus stent (visually identical) without drug coating

Non coated

Eligibility Criteria

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

You may qualify if:

  • Patient has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration.
  • Patient is indicated for and has consented to FESS.
  • FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement.
  • CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
  • Patient has minimum total CT score (Lund-Mackay method) of 6. • Patient has bilateral ethmoid sinus disease confirmed by CT.

You may not qualify if:

  • insulin dependent diabetics
  • oral steroid dependent condition
  • glaucoma, ocular hypertension, posterior subcapsular cataracts
  • middle turbinate resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Central California ENT

Fresno, California, 93720, United States

Location

Colorado ENT & Allergy

Colorado Springs, Colorado, 80909, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Northshore University Health System

Evanston, Illinois, 60201, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40207, United States

Location

Charlotte Eye, ENT Associates

Charlotte, North Carolina, 28210, United States

Location

Austin ENT Clinics

Austin, Texas, United States

Location

University of Texas SW Medical School

Dallas, Texas, United States

Location

University of Texas Medical School

Houston, Texas, 77098, United States

Location

Intermountain ENT

Salt Lake City, Utah, 84102, United States

Location

Eastern Virgina Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

  • Han JK, Marple BF, Smith TL, Murr AH, Lanier BJ, Stambaugh JW, Mugglin AS. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol. 2012 Jul-Aug;2(4):271-9. doi: 10.1002/alr.21044. Epub 2012 May 1.

    PMID: 22550039RESULT

Results Point of Contact

Title
James Stambaugh, Vice President Clinical Affairs
Organization
Intersect ENT
jstambaugh@intersectent.com
650-641-2103

Study Officials

  • Bradley Marple, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

  • Neil Bhattacharyya, MD

    Brighan & Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

December 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

June 22, 2015

Results First Posted

April 13, 2015

Record last verified: 2015-05

Locations

US(11)