Clinical trial

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

NCT00626366

Name

0498-07-FB

Description

The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.

Trial arms

Trial start

2008-03-12

Estimated PCD

2009-01-09

Trial end

2009-01-09

Status

Completed

Treatment

Sinus CT Scan

Subjects will undergo a Xoran miniCAT scan of their sinuses

Arms:

Nasal drop, Nasal spray

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.

Arms:

Nasal spray

Other names:

contrast enhancement

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.

Arms:

Nasal drop

Other names:

contrast enhancement

Size

Primary endpoint

To Measure the Distribution of Nasal Sprays and Drops.

2 months

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

Updated at

2023-09-28

1 organization

1 product

1 indication

Organization

University of Nebraska

Product

Omnipaque 240

Indication

Chronic Rhinosinusitis