Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of Nebraska.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00626366
First received: February 20, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

The purpose of this study is to determine the distribution of nasal sprays and nasal drops. We hypothesize that nasal drops will reach the frontonasal region more often than nasal sprays.


Condition Intervention
Chronic Sinusitis
Radiation: Sinus CT Scan
Drug: Omnipaque 240 Contrast Solution
Drug: Omnipaque 240 mg I/mL

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • To determine the distribution of nasal sprays and drops. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: March 2008
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.
Radiation: Sinus CT Scan
Subjects will undergo a Xoran miniCAT scan of their sinuses
Drug: Omnipaque 240 Contrast Solution
Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
Experimental: 2
This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.
Radiation: Sinus CT Scan
Subjects will undergo a Xoran miniCAT scan of their sinuses
Drug: Omnipaque 240 mg I/mL
Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult able to perform activities of daily living

Exclusion Criteria:

  • signs or symptoms of acute or chronic paranasal sinus disease
  • history of sinus surgery
  • symptomatic deviated septum
  • active seasonal allergies
  • allergies to contrast
  • history of nasal polyposis
  • pregnant or breast feeding women
  • neck or back problems that would prevent a subject from kneeling on the floor and crouching over
  • currently taking metformin or amiodarone
  • students or stff under the direct supervision of the investigators
  • cognitive impairment
  • terminal illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626366

Contacts
Contact: Kelli L Olechoski, BA 402-689-0767 kolechos@unmc.edu
Contact: Erin K O'Brien, MD 402-559-7777 eobrien@unmc.edu

Locations
United States, Nebraska
ENT Specialist PC of Omaha Not yet recruiting
Omaha, Nebraska, United States, 68114
Contact: Kelli L Olechoski, BA    402-689-0767    kolechos@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Erin K O'Brien, MD UNMC Department of Otolaryngology
Study Chair: Donald Leopold, MD UNMC Department of Otolaryngology
  More Information

Publications:
Responsible Party: Erin O'Brien MD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00626366     History of Changes
Other Study ID Numbers: 498-07-FB
Study First Received: February 20, 2008
Last Updated: February 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Nasal Spray
Nasal Drop
Intranasal Medication

Additional relevant MeSH terms:
Pharmaceutical Solutions
Iohexol
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 18, 2014