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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02079792
First Posted: March 6, 2014
Last Update Posted: April 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada
  Purpose
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.

Condition Intervention Phase
Sinusitis Procedure: Lying Head Back Position Procedure: Head Down and Forward Position Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device: A Randomized, Single-blind, Parallel Trial Comparing the Lying-Head-Back Versus the Head-Down-to-Floor Positions

Resource links provided by NLM:


Further study details as provided by Amin Javer, St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • Endoscopic sinonasal mucosal inflammation [ Time Frame: Participants will be followed for the duration of their treatment, an expected average of 12 weeks. ]
    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.


Secondary Outcome Measures:
  • Quality of Life (via SNOT-22) [ Time Frame: Participants will be followed for the duration of their treatment, an expected average of 12 weeks. ]
    Sino-Nasal Outcome Test (SNOT-22) is current standard in Rhinology for the assessment of the patient's subjective sinus symptoms and its effect on their daily functioning. Using the SNOT-22, patient quality of life will be assessed at the baseline, 6 weeks, and 12 weeks clinic visit. SNOT-22 change in score between patients in the LHB vs HDF group will be compared between baseline and after 12 weeks of treatment.


Enrollment: 66
Study Start Date: June 2014
Study Completion Date: August 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lying Head Back Position
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
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.
Other Names:
  • Active comparator
  • Control
  • LHB
  • Mygind Position
Experimental: Head Down and Forward Position
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
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.
Other Names:
  • Experimental arm
  • Mecca Postion
  • HDF

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079792


Locations
Canada, British Columbia
St. Paul's Hospital Sinus Centre
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
Principal Investigator: Amin R Javer, MD, FRCSC, FARS St. Paul's Hospital, Canada
  More Information

Publications:
Responsible Party: Amin Javer, Director, St. Paul's Sinus Centre, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT02079792     History of Changes
Other Study ID Numbers: HeadPositionMAD2014
First Submitted: March 4, 2014
First Posted: March 6, 2014
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
Budesonide
Mucosal Atomization Device
Head Position

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists