The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device

NCT02079792 | Completed Phase 4

• 1 other identifier: HeadPositionMAD2014
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Rhinosinusitis (CRS) is a common disorder of the nose characterized by stuffy nose, discoloured nasal discharge, sinus congestion or pressure and decreased sense of smell, present for over twelve weeks. Anti-inflammatory steroid medication is often used to treat sinus inflammation in CRS. These steroids are sometimes delivered using a spray device that creates a mist to deliver steroid medication deep into the nose. However, the distribution and efficacy of sprayed medication can be affected by the position of the patient's head. This study aims to determine which of two head positions is best for delivering steroid to the sinuses.

Conditions

Sinusitis

Keywords

Budesonide; Mucosal Atomization Device; Head Position

Outcome Measures

Primary Outcomes (1)

• Endoscopic sinonasal mucosal inflammation

  The primary objective of this clinical trial is to compare endoscopic sinonasal mucosal inflammation between patients oriented in the LHB and HDF position after 6 and 12 weeks of treatment. Subject sinus cavities will be assessed by a validated endoscopic mucosal staging system first at baseline, then at 6 weeks and 12 weeks of treatment. Total scores will be compared between the treatment groups. The Lund-Kennedy (LKES) and Philpott-Javer (PJES) endoscopic staging systems will be utilized to quantify the severity of sinonasal disease. The Principal Investigator will complete all endoscopic evaluations and will be blind to treatment allocation.

  Participants will be followed for the duration of their treatment, an expected average of 12 weeks.

Secondary Outcomes (1)

• Quality of Life (via SNOT-22)

  Participants will be followed for the duration of their treatment, an expected average of 12 weeks.

Study Arms (2)

Lying Head Back Position

ACTIVE COMPARATOR

Subjects randomized to the LHB position will be instructed to lay supine on the clinical table, with their head hanging over the edge of the bed as far as possible without discomfort. Subjects will be instructed to administer budesonide 1mg/2cc nebules daily for 12 weeks using the MAD syringe, in the head position to which they were randomized.

Procedure: Lying Head Back Position

Head Down and Forward Position

EXPERIMENTAL

Subjects randomized to the HDF position will be instructed to kneel down, placing the top of their head on the ground and forehead close to the knees with the nostrils facing upwards. Subjects will be instructed to administer budesonide 1mg/2cc nebules daily for 12 weeks using the MAD syringe, in the head position to which they were randomized.

Procedure: Head Down and Forward Position

Interventions

Lying Head Back Position PROCEDURE

Subjects randomized to the LHB position will be instructed to lay supine on the clinical table, with their head hanging over the edge of the bed as far as possible without discomfort.

Also known as: Active comparator, Control, LHB, Mygind Position

Lying Head Back Position

Head Down and Forward Position PROCEDURE

Subjects randomized to the HDF position will be instructed to kneel down, placing the top of their head on the ground and forehead close to the knees with the nostrils facing upwards.

Also known as: Experimental arm, Mecca Postion, HDF

Head Down and Forward Position

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years and older.
• Diagnosed with CRS according to the Canadian Practice Guidelines for Acute and Chronic Rhinosinusitis2.
• Having previously received complete bilateral FESS, which includes uncinectomy, anterior and posterior ethmoidectomy, maxillary antrostomy, sphenoidotomy and frontal sinusotomy, at least 3 months prior to receiving the study intervention.
• Individuals presenting with sinonasal mucosal edema that warrant treatment with nasally administered Budesonide.

You may not qualify if:

• Patients unable to speak, read, or write English.
• Females who are pregnant.
• Presenting with septal deviations and/or perforations.
• Patients already taking oral or topical steroids at the time of enrollment 3-months post-FESS
• Prior history of facial trauma or presenting with anatomical abnormalities that may affect spray distribution. Abnormalities can include middle turbinate lateralization, and/or previously resected middle or inferior turbinates..
• Previous history of extensive sinus surgery (e.g. open sinus surgery, endoscopic endonasal tumor resection, modified Lothrop procedure).
• Patients unable to physically orient themselves in either study position due to severe obesity or joint/muscle pain.
• Cystic fibrosis, primary ciliary dyskinesia patients, diabetes, or hypertension.

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

St. Paul's Hospital Sinus Centre

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (6)

• Manes RP, Tong L, Batra PS. Prospective evaluation of aerosol delivery by a powered nasal nebulizer in the cadaver model. Int Forum Allergy Rhinol. 2011 Sep-Oct;1(5):366-71. doi: 10.1002/alr.20057. Epub 2011 May 9.

  PMID: 22287468 BACKGROUND

• Cannady SB, Batra PS, Citardi MJ, Lanza DC. Comparison of delivery of topical medications to the paranasal sinuses via "vertex-to-floor" position and atomizer spray after FESS. Otolaryngol Head Neck Surg. 2005 Nov;133(5):735-40. doi: 10.1016/j.otohns.2005.07.039.

  PMID: 16274802 BACKGROUND

• Grobler A, Weitzel EK, Buele A, Jardeleza C, Cheong YC, Field J, Wormald PJ. Pre- and postoperative sinus penetration of nasal irrigation. Laryngoscope. 2008 Nov;118(11):2078-81. doi: 10.1097/MLG.0b013e31818208c1.

  PMID: 18641522 BACKGROUND

• Singhal D, Weitzel EK, Lin E, Feldt B, Kriete B, McMains KC, Thwin M, Wormald PJ. Effect of head position and surgical dissection on sinus irrigant penetration in cadavers. Laryngoscope. 2010 Dec;120(12):2528-31. doi: 10.1002/lary.21092.

  PMID: 21058393 BACKGROUND

• Bateman ND, Whymark AD, Clifton NJ, Woolford TJ. A study of intranasal distribution of azelastine hydrochloride aqueous nasal spray with different spray techniques. Clin Otolaryngol Allied Sci. 2002 Oct;27(5):327-30. doi: 10.1046/j.1365-2273.2002.00589.x.

  PMID: 12383290 BACKGROUND

• Valentine R, Athanasiadis T, Thwin M, Singhal D, Weitzel EK, Wormald PJ. A prospective controlled trial of pulsed nasal nebulizer in maximally dissected cadavers. Am J Rhinol. 2008 Jul-Aug;22(4):390-4. doi: 10.2500/ajr.2008.22.3191.

  PMID: 18702903 BACKGROUND

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Amin R Javer, MD, FRCSC, FARS

  St. Paul's Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, St. Paul's Sinus Centre

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

CA (1)