Chronic SinusitisNCT00626366
Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison
A study testing Sinus CT Scan, Omnipaque 240 Contrast Solution and Omnipaque 240 mg I/mL in people with Chronic Sinusitis, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Sinus CT Scan, Omnipaque 240 Contrast Solution and Omnipaque 240 mg I/mL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2008to 9 Jan 2009
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult able to perform activities of daily living
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.
Read the detailed description
The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. The study hypothesizes that nasal drops will reach the frontonasal region more often than nasal sprays.
- Conditions
- Chronic Sinusitis
- Being tested
- Sinus CT Scan, Omnipaque 240 Contrast Solution, Omnipaque 240 mg I/mL
- Keywords
- Nasal Spray, Nasal Drop, Intranasal Medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus CT ScanRadiation
Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 Contrast SolutionDrug
Also called contrast enhancement
Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
Omnipaque 240 mg I/mLDrug
Also called contrast enhancement
Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.
| Study group | Role | What they receive |
|---|---|---|
| Nasal spray | Experimental | 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. Receives: Radiation: Sinus CT Scan; Drug: Omnipaque 240 Contrast Solution |
| Nasal drop | Experimental | 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. Receives: Radiation: Sinus CT Scan; Drug: Omnipaque 240 mg I/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure the Distribution of Nasal Sprays and Drops.
CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study start12 Mar 2008
- Primary completion9 Jan 2009
- Study completion9 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin K O'Brien, MD, Principal investigator, University of NebraskaDonald Leopold, MD, Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626366
- Sponsor's protocol ID
- 0498-07-FB
- Status last verified
- Sep 2023
- First submitted
- 20 Feb 2008
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Senocak D, Senocak M, Bozan S. Sinonasal distribution of topically applied particles: computerized tomographic detection and the effects of topical decongestion. Otolaryngol Head Neck Surg. 2005 Dec;133(6):944-8. doi: 10.1016/j.otohns.2005.08.024.
PubMed 16360518Olson DE, Rasgon BM, Hilsinger RL Jr. Radiographic comparison of three methods for nasal saline irrigation. Laryngoscope. 2002 Aug;112(8 Pt 1):1394-8. doi: 10.1097/00005537-200208000-00013.
PubMed 12172251Wormald PJ, Cain T, Oates L, Hawke L, Wong I. A comparative study of three methods of nasal irrigation. Laryngoscope. 2004 Dec;114(12):2224-7. doi: 10.1097/01.mlg.0000149463.95950.c5.
PubMed 15564850Boatsman JE, Calhoun KH, Ryan MW. Relationship between rhinosinusitis symptoms and mucociliary clearance time. Otolaryngol Head Neck Surg. 2006 Mar;134(3):491-3. doi: 10.1016/j.otohns.2005.10.045.
PubMed 16500451Lund VJ, Black JH, Szabo LZ, Schrewelius C, Akerlund A. Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Rhinology. 2004 Jun;42(2):57-62.
PubMed 15224630Aukema AA, Fokkens WJ. Chronic rhinosinusitis: management for optimal outcomes. Treat Respir Med. 2004;3(2):97-105. doi: 10.2165/00151829-200403020-00004.
PubMed 15182211Cannady 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.
PubMed 16274802