Chronic Frontal RhinosinusitisPhase 2NCT02862509
Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position
A Phase 2 study testing Budesonide nasal instillation and Normal saline nasal instillation in people with Chronic Frontal Rhinosinusitis and Vertex to Floor Position, run by Khon Kaen University at 2 sites in Thailand.
Trial summary
o Chronic rhinosinusitis is one of the most common health issue affected American population. Surgery plays an important role in the patients who failed the medical treatment. The most difficult location to be operated endoscopically is the frontal sinus. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chronic Frontal Rhinosinusitis, Vertex to Floor Position
- What is being tested?
- Budesonide nasal instillation and Normal saline nasal instillation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesThailand
- Study dates
- Nov 2015to Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic rhinosinusitis with frontal sinusitis patient
- Age ≥12
- Post-frontal sinus surgery with frontal sinus opening>3mm
- Satisfactory surgical technique: adequate sinus osteal drainage and mucosal sparing technique
Who cannot join
- Isolated frontal sinus surgery
- History of previous head and neck radiation
- Previous nasal or sinus operation
- Clinically significant deviated nasal septum
- History of paranasal sinus tumor
- Known immunocompromised Host
Show all 9Show fewer
- History of budesonide allergy
- Cannot provide full flexion of the neck (cannot perform vertex-to-floor position)
- Post-randomization exclusion: Pathologic invasive fungal infection
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, 10330
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position in Chronic Rhinosinusitis Patients Underwent Endoscopic Frontal Sinus Surgery: a Randomized, Controlled Trial.
- Chronic rhinosinusitis is one of the most common health issue affected American population. Surgery plays an important role in the patients who failed the medical treatment. The most difficult location to be operated endoscopically is the frontal sinus. Frontal sinus is also found to be one of the most common sinus for residual and recurrence after the operation. Intranasal steroid seems to be one of the most beneficent post-sinus surgery cares. The topical therapy can be delivered by many approaches. According to the standard clinical practice guideline and recommendations, intranasal corticosteroid spray is suggested. The technique proved to have greater distribution than standard intranasal spray is instillation of steroid nose drops. The head position for instillation of steroid nose drops proven to have a greater access to olfactory cleft and frontal area is Vertex-to-floor position.
- Being tested
- Budesonide nasal instillation, Normal saline nasal instillation
- Keywords
- Post-frontal sinus operation chronic rhinosinusitis patients, Budesonide nasal instillation, Vertex to floor position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide nasal instillationDrug
Normal saline nasal instillationDrug
| Study group | Role | What they receive |
|---|---|---|
| Budesonide nasal instillation | Experimental | budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily Receives: Drug: Budesonide nasal instillation |
| Normal saline nasal instillation | Placebo comparator | Normal saline solution instilled in vertex to floor position daily Receives: Drug: Normal saline nasal instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sinonasal outcome test (SNOT) 20 score (validated Thai version)
Measured: three months
Secondary outcomes (2)
Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES)
Measured: three months
Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic Frontal RhinosinusitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navarat Vatcharayothin, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862509
- Sponsor's protocol ID
- HE581299
- Status last verified
- Aug 2016
- First submitted
- 16 Jul 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Halawi AM, Smith SS, Chandra RK. Chronic rhinosinusitis: epidemiology and cost. Allergy Asthma Proc. 2013 Jul-Aug;34(4):328-334. doi: 10.2500/aap.2013.34.3675.
PubMed 23883597Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161.
PubMed 24819891Bhattacharyya N. Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States. Ann Otol Rhinol Laryngol. 2011 Jul;120(7):423-7. doi: 10.1177/000348941112000701.
PubMed 21859049Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
PubMed 22469599Grobler A, Weitzel EK, Buele A, Jardeleza C, Cheong YC, Field J, Wormald PJ. Pre- and postoperative sinus penetration of nasal irrigation. Laryngoscope. 2008 Nov;118(11):2078-81. doi: 10.1097/MLG.0b013e31818208c1.
PubMed 18641522Musy PY, Kountakis SE. Anatomic findings in patients undergoing revision endoscopic sinus surgery. Am J Otolaryngol. 2004 Nov-Dec;25(6):418-22. doi: 10.1016/j.amjoto.2004.06.002.
PubMed 15547811Harvey RJ, Goddard JC, Wise SK, Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation. Otolaryngol Head Neck Surg. 2008 Jul;139(1):137-42. doi: 10.1016/j.otohns.2008.04.020.
PubMed 18585576Miller TR, Muntz HR, Gilbert ME, Orlandi RR. Comparison of topical medication delivery systems after sinus surgery. Laryngoscope. 2004 Feb;114(2):201-4. doi: 10.1097/00005537-200402000-00004.
PubMed 14755189Harvey RJ, Debnath N, Srubiski A, Bleier B, Schlosser RJ. Fluid residuals and drug exposure in nasal irrigation. Otolaryngol Head Neck Surg. 2009 Dec;141(6):757-61. doi: 10.1016/j.otohns.2009.09.006.
PubMed 19932850Hardy JG, Lee SW, Wilson CG. Intranasal drug delivery by spray and drops. J Pharm Pharmacol. 1985 May;37(5):294-7. doi: 10.1111/j.2042-7158.1985.tb05069.x.
PubMed 2862235Aoki FY, Crowley JC. Distribution and removal of human serum albumin-technetium 99m instilled intranasally. Br J Clin Pharmacol. 1976 Oct;3(5):869-78. doi: 10.1111/j.1365-2125.1976.tb00640.x.
PubMed 973982Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
PubMed 19793277Snidvongs K, Dalgorf D, Kalish L, Sacks R, Pratt E, Harvey RJ. Modified Lund Mackay Postoperative Endoscopy Score for defining inflammatory burden in chronic rhinosinusitis. Rhinology. 2014 Mar;52(1):53-59. doi: 10.4193/Rhino13.056.
PubMed 24618629
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position in Chronic Rhinosinusitis Patients Underwent Endoscopic Frontal Sinus Surgery: a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02862509
- Acronym / sponsor ID
- HE581299
- Keywords
- Post-frontal sinus operation chronic rhinosinusitis patients, Budesonide nasal instillation, Vertex to floor position
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Chronic rhinosinusitis is one of the most common health issue affected American population. Surgery plays an important role in the patients who failed the medical treatment. The most difficult location to be operated endoscopically is the frontal sinus. Frontal sinus is also found to be one of the most common sinus for residual and recurrence after the operation. Intranasal steroid seems to be one of the most beneficent post-sinus surgery cares. The topical therapy can be delivered by many approaches. According to the standard clinical practice guideline and recommendations, intranasal corticosteroid spray is suggested. The technique proved to have greater distribution than standard intranasal spray is instillation of steroid nose drops. The head position for instillation of steroid nose drops proven to have a greater access to olfactory cleft and frontal area is Vertex-to-floor position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide nasal instillation | Experimental | Drug: Budesonide nasal instillationbudesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily |
| Normal saline nasal instillation | Placebo comparator | Drug: Normal saline nasal instillationNormal saline solution instilled in vertex to floor position daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic rhinosinusitis with frontal sinusitis patient
- Age ≥12
- Post-frontal sinus surgery with frontal sinus opening>3mm
- Satisfactory surgical technique: adequate sinus osteal drainage and mucosal sparing technique
Key exclusion criteria (9 listed)
- Isolated frontal sinus surgery
- History of previous head and neck radiation
- Previous nasal or sinus operation
- Clinically significant deviated nasal septum
- History of paranasal sinus tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide nasal instillation | Drug | Budesonide nasal instillation |
| Normal saline nasal instillation | Drug | Normal saline nasal instillation |
Primary outcome
Total Sinonasal outcome test (SNOT) 20 score (validated Thai version)
Time frame: three months
2 secondary outcomes
Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES)
Time frame: three months
Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version)
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Results publication: PubMed 23883597Halawi AM, Smith SS, Chandra RK. Chronic rhinosinusitis: epidemiology and cost. Allergy Asthma Proc. 2013 Jul-Aug;34(4):328-334. doi: 10.2500/aap.2013.34.3675.
- Results publication: PubMed 24819891Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161.
- Results publication: PubMed 21859049Bhattacharyya N. Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States. Ann Otol Rhinol Laryngol. 2011 Jul;120(7):423-7. doi: 10.1177/000348941112000701.
- Results publication: PubMed 22469599Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
- Results publication: PubMed 18641522Grobler A, Weitzel EK, Buele A, Jardeleza C, Cheong YC, Field J, Wormald PJ. Pre- and postoperative sinus penetration of nasal irrigation. Laryngoscope. 2008 Nov;118(11):2078-81. doi: 10.1097/MLG.0b013e31818208c1.
- Results publication: PubMed 15547811Musy PY, Kountakis SE. Anatomic findings in patients undergoing revision endoscopic sinus surgery. Am J Otolaryngol. 2004 Nov-Dec;25(6):418-22. doi: 10.1016/j.amjoto.2004.06.002.
- Results publication: PubMed 18585576Harvey RJ, Goddard JC, Wise SK, Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation. Otolaryngol Head Neck Surg. 2008 Jul;139(1):137-42. doi: 10.1016/j.otohns.2008.04.020.
- Results publication: PubMed 14755189Miller TR, Muntz HR, Gilbert ME, Orlandi RR. Comparison of topical medication delivery systems after sinus surgery. Laryngoscope. 2004 Feb;114(2):201-4. doi: 10.1097/00005537-200402000-00004.
- Results publication: PubMed 19932850Harvey RJ, Debnath N, Srubiski A, Bleier B, Schlosser RJ. Fluid residuals and drug exposure in nasal irrigation. Otolaryngol Head Neck Surg. 2009 Dec;141(6):757-61. doi: 10.1016/j.otohns.2009.09.006.
- Results publication: PubMed 2862235Hardy JG, Lee SW, Wilson CG. Intranasal drug delivery by spray and drops. J Pharm Pharmacol. 1985 May;37(5):294-7. doi: 10.1111/j.2042-7158.1985.tb05069.x.
- Results publication: PubMed 973982Aoki FY, Crowley JC. Distribution and removal of human serum albumin-technetium 99m instilled intranasally. Br J Clin Pharmacol. 1976 Oct;3(5):869-78. doi: 10.1111/j.1365-2125.1976.tb00640.x.
- Results publication: PubMed 19793277Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide nasal instillation and Normal saline nasal instillation in people with Chronic Frontal Rhinosinusitis and Vertex to Floor Position, run by Khon Kaen University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sinonasal outcome test (SNOT) 20 score (validated Thai version) (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862509, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.