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

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ClinicalTrials.gov Identifier: NCT00626366
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Erin O'Brien, University of Nebraska

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Sinusitis Radiation: Sinus CT Scan Drug: Omnipaque 240 Contrast Solution Drug: Omnipaque 240 mg I/mL Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison
Actual Study Start Date : March 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. To determine the distribution of nasal sprays and drops. [ Time Frame: 2 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00626366


Locations
United States, Nebraska
ENT Specialist PC of Omaha
Omaha, Nebraska, United States, 68114
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

Publications of Results:
Responsible Party: Erin O'Brien, Principal investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00626366     History of Changes
Other Study ID Numbers: 498-07-FB
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Keywords provided by Erin O'Brien, University of Nebraska:
Nasal Spray
Nasal Drop
Intranasal Medication

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pharmaceutical Solutions