NCT01575223

Brief Summary

Purpose: To determine if high volume saline nasal irrigation (HVSI), (NeilMed® Sinus Rinse™) offers a benefit over low volume saline irrigation (LVSI), (Salinex®) in the early post-operative management in patients with chronic rhino sinusitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2012

Typical duration for phase_4

Geographic Reach
1 country

4 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

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

2.1 years

First QC Date

April 1, 2012

Last Update Submit

April 22, 2014

Conditions

Chronic Rhinosinusitis

Keywords

saline irrigationchronic rhinosinusitisendoscopic sinus surgeryhigh volume saline irrigation

Outcome Measures

Primary Outcomes (4)

  • Sinonasal Outcomes Scale (SNOT-22)

    Subjective scale, completed by patient. Validated scale for chronic sinusitis.

    One month post-operatively

  • Lund MacKay score

    Objective scale, validated, completed by investigator. Preoperative CT scan is scored based on degree of sinus opacification (0-24).

    1 month postoperatively

  • Nasal and Sinus Symptom Score (NSS) - Subjective scale

    A subjective scale, filled out by the patient, specific to symptoms of sinusitis.

    1 month post-operatively

  • Perioperative Sinus Endoscopy scale (POSE)

    Objective scale, completed by treating physician, to assess sinonasal contents endoscopically. Validated scale.

    1 month post-operatively

Study Arms (2)

High volume saline irrigation

ACTIVE COMPARATOR

Patients in this group will receive high volume saline irrigation (NeilMed sinus rinse)

Device: NeilMed sinus rinse

Placebo

PLACEBO COMPARATOR

Patients in this group will receive low volume saline irrigation (Salinex)

Device: Salinex

Interventions

NeilMed sinus rinseDEVICE

High volume saline irrigation

High volume saline irrigation
SalinexDEVICE

Low volume saline irrigation

Placebo

Eligibility Criteria

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

You may qualify if:

  • Documented diagnosis of unilateral or bilateral CRS
  • Documented failed medical treatment of CRS
  • Eighteen (18) to sixty-five (65) years of age
  • Planned ESS for the treatment of CRS
  • Able to read and understand English

You may not qualify if:

  • Pregnant
  • Cystic Fibrosis
  • Diagnosed immotile cilia syndrome
  • Diagnosed immunodeficiency syndrome
  • Diagnosed fungal sinusitis
  • Sinonasal tumours or obstructive lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Calgary Otolaryngology - Head & Neck Surgery

Calgary, Alberta, T5J 3E4, Canada

Location

Western University Dept. of Otolaryngology - Head & Neck Surgery

London, Ontario, N6A 3K7, Canada

Location

Ottawa University Otolaryngology - Head & Neck Surgery

Ottawa, Ontario, K1Y 4E9, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (5)

  • Desrosiers M, Evans GA, Keith PK, Wright ED, Kaplan A, Bouchard J, Ciavarella A, Doyle PW, Javer AR, Leith ES, Mukherji A, Robert Schellenberg R, Small P, Witterick IJ. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. J Otolaryngol Head Neck Surg. 2011 May;40 Suppl 2:S99-193. English, French.

    PMID: 21658337BACKGROUND

  • Chen Y, Dales R, Lin M. The epidemiology of chronic rhinosinusitis in Canadians. Laryngoscope. 2003 Jul;113(7):1199-205. doi: 10.1097/00005537-200307000-00016.

    PMID: 12838019BACKGROUND

  • Anand VK. Epidemiology and economic impact of rhinosinusitis. Ann Otol Rhinol Laryngol Suppl. 2004 May;193:3-5. doi: 10.1177/00034894041130s502.

    PMID: 15174752BACKGROUND

  • Ray NF, Baraniuk JN, Thamer M, Rinehart CS, Gergen PJ, Kaliner M, Josephs S, Pung YH. Healthcare expenditures for sinusitis in 1996: contributions of asthma, rhinitis, and other airway disorders. J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):408-14. doi: 10.1016/s0091-6749(99)70464-1.

    PMID: 10069873BACKGROUND

  • Harvey RJ, Debnath N, Srubiski A, Bleier B, Schlosser RJ. Fluid residuals and drug exposure in nasal irrigation. Otolaryngol Head Neck Surg. 2009 Dec;141(6):757-61. doi: 10.1016/j.otohns.2009.09.006.

    PMID: 19932850BACKGROUND

Study Officials

  • Ian J Witterick, MD MSc FRCSC

    Samuel R Lunenfeld Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2012

First Posted

April 11, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 23, 2014

Record last verified: 2014-04

Locations

CA(4)