Chronic Rhinosinusitis (Diagnosis)Phase 3NCT03303677
Comparison of Topical Therapies in Post op Endoscopic Sinus Surgery Patients
A Phase 3 study testing Saline Nasal, Budesonide Nasal and Topical Antibacterial (Product) in people with Chronic Rhinosinusitis (Diagnosis), run by University of Florida at 1 site in United States.
Trial summary
The goal of the study is to compare postoperative symptom scores and endoscopy findings between in patients who receive either nasal saline rinses, saline + budesonide, and saline + topical antibiotics and budesonide following endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Saline Nasal, Budesonide Nasal and Topical Antibacterial (Product)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 1 Nov 2019
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Chronic rhinosinusitis (CRS) defined by symptom, endoscopic, and radiographic criteria who are undergoing endoscopic sinus surgery
Who cannot join
- Age <18
- endoscopic sinus surgery for reason other than CRS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Post op Outcomes in Endoscopic Sinus Surgery Using Varying Nasal Sinus Irrigations. Saline vs. Saline and Budesonide vs Saline, Budesonide, and Culture Directed Topical Antibiotics
The goal of the study is to compare postoperative symptom scores and endoscopy findings between in patients who receive either nasal saline rinses, saline + budesonide, and saline + topical antibiotics and budesonide following endoscopic sinus surgery.
Read the detailed description
The group of patients from which the study tem will recruit consists of patients referred to the University of Florida tertiary referral rhinology practice of Dr. Jeb Justice and Dr. William Collins. Patients with CRS defined by symptom, endoscopic, and radiographic criteria who are candidates for surgical intervention will be identified by the above-mentioned investigators. As part of their initial pre operative work up they will be asked to fill out SNOT-22 and RSDI surveys. As part of their surgery intraoperative cultures will be obtained from the surgically opened sinus cavities. The above radiologic, endoscopic procedures, cultures and QOL/symptoms surveys are typical in the workup of patients who present with rhinologic related problems. None of the above tests will be undertaken for the sole purpose of this study.
If the patient meets criteria, he/she will be approached by one of the investigators about participating in the research study. Information regarding the study, including the informed consent form, will be extensively discussed. If the patient agrees to take part in this study, the consent form will be provided for review and will then be signed. This consent form will be kept in a secure locked location with access given only to study staff identified in the Institutional Review Board (IRB) protocol. It will be explained to the patients that there is no obligation for them to participate in the study and that they can drop out of the study at any time without repercussions regarding their care.
If a patient elects to be a part of the study they will be randomized into one of three treatment arms. This process will be done by placing an equal number of note cards in envelopes. The note cards will contain either a "1", "2", or "3" to represent the different treatment arms. These will be placed in the envelopes, shuffled, and kept in a box in the otolaryngology clinic. At the patient's first postoperative appointment an envelope is drawn and it is documented which treatment arm the patient will be treated under.
All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm. The first treatment arm will consist of patients that are given only saline nasal irrigations to be performed twice daily. The second arm will be given a prescription for nasal saline + budesonide to be performed twice daily. The final arm will be given a prescription for nasal saline + budesonide + a culture directed topical antibiotic. These treatments are commonly used in our practice and will be obtained through the compounding pharmacies that are already in use by our practice.
Patients will be seen in follow up at 1-2 week, 3-4 week, 6-8 week, and 10-12 week follow up appointments. At each of these appointments they will undergo nasal endoscopy and debridement as is standard following endoscopic sinus surgery. They will also be asked to fill out SNOT-22 and RSDI surveys to monitor their progression.
The RSDI contains 30 questions designed to measure the patient's disease-specific status in the physical, emotional, and functional domains. The questions present the patient with symptoms and ask if there experience the symptoms never, almost never, sometimes, almost always, and always. These are scored as 0-4, with never getting a score of 0 and always getting a score of 4 for a total score range of 0-120.
The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5 where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it possibly can be. The Snot-22 has a cumulative score of 0-110.
Endoscopy findings will be scored using the Lund-Kennedy endoscopy scoring system. This system grades the endoscopic findings within the paranasal sinuses for the presence of: polyps, discharge, edema, scarring and crusting . Each side of the nasal cavity is scored separately and then combined for the total score. Polyps are scored as absent (0), present in middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0), thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal cavity a total score from 0-20 is found.
Final data will compare the pre and postoperative SNOT-22 and RSDI surveys, endoscopy findings, need for oral antibiotics, and need for oral steroids for the three treatment arms.
Cultures will be obtained for all patients during endoscopic sinus surgery as is our standard practice. During treatment patients will be treated as per standard which could include the use of oral antibiotics, oral steroids, or nasal steroid sprays as their medical condition warrants.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Saline Nasal, Budesonide Nasal, Topical Antibacterial (Product)
- Keywords
- endoscopic sinus surgery, topical nasal therapy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline NasalDrug
topical nasal saline rinses
Budesonide NasalDrug
saline + budesonide nasal saline irrigation
Topical Antibacterial (Product)Drug
Also called Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole
The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole
| Study group | Role | What they receive |
|---|---|---|
| Saline | Active comparator | Post operative endoscopic sinus surgery patients using Saline nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm. Receives: Drug: Saline Nasal |
| Saline and budesonide | Experimental | Post operative endoscopic sinus surgery patients using saline + budesonide nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm. Receives: Drug: Saline Nasal; Drug: Budesonide Nasal |
| saline, budesonide, and topical antibiotic | Experimental | Post operative endoscopic sinus surgery patients using saline + budesonide + topical antibiotic nasal sinus irrigations. The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm. Receives: Drug: Saline Nasal; Drug: Budesonide Nasal; Drug: Topical Antibacterial (Product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom scores on Sino-nasal Outcome Test (SNOT)-22 surveys
The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5 where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it possibly can be. The Snot-22 has a cumulative score of 0-110.
Measured: Up to 12 weeks post op
Change in symptom scores on Rhinosinusitis Disability Index (RSDI)
The RSDI contains 30 questions designed to measure the patient's disease-specific status in the physical, emotional, and functional domains. The questions present the patient with symptoms and ask if there experience the symptoms never, almost never, sometimes, almost always, and always. These are scored as 0-4, with never getting a score of 0 and always getting a score of 4 for a total score range of 0-120.
Measured: Up to 12 weeks post op
Nasal endoscopy findings
Lund-Kennedy endoscopy scoring system. This system grades the endoscopic findings within the paranasal sinuses for the presence of: polyps, discharge, edema, scarring and crusting. Each side of the nasal cavity is scored separately and then combined for the total score. Polyps are scored as absent (0), present in middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0), thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal cavity a total score from 0-20 is found
Measured: Up to 12 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Apr 2018 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2019 (estimated)
Why it stopped: Withdrawn by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization into one of three treatment arms
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeb Justice, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303677
- Sponsor's protocol ID
- IRB201701952
- Status last verified
- Mar 2018
- First submitted
- 26 Sep 2017
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.
PubMed 25832968Rawal RB, Deal AM, Ebert CS Jr, Dhandha VH, Mitchell CA, Hang AX, Gore MR, Senior BA, Zanation AM. Post-operative budesonide irrigations for patients with polyposis: a blinded, randomized controlled trial. Rhinology. 2015 Sep;53(3):227-34. doi: 10.4193/Rhino14.196.
PubMed 26363164Lee VS, Davis GE. Culture-directed topical antibiotic treatment for chronic rhinosinusitis. Am J Rhinol Allergy. 2016 Nov 1;30(6):414-417. doi: 10.2500/ajra.2016.30.4380.
PubMed 28124652Lim M, Citardi MJ, Leong JL. Topical antimicrobials in the management of chronic rhinosinusitis: a systematic review. Am J Rhinol. 2008 Jul-Aug;22(4):381-9. doi: 10.2500/ajr.2008.22.3189.
PubMed 18702902Rudmik L, Smith TL. Evidence-based practice: postoperative care in endoscopic sinus surgery. Otolaryngol Clin North Am. 2012 Oct;45(5):1019-32. doi: 10.1016/j.otc.2012.06.006.
PubMed 22980682Portela RA, Hootnick J, McGinn J. Perioperative care in functional endoscopic sinus surgery: a survey study. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):27-33. doi: 10.1002/alr.20098. Epub 2011 Oct 24.
PubMed 22311838Kim ST, Sung UH, Jung JH, Paik JY, Woo JH, Cha HE, Kang IG. The effect of maxillary sinus irrigation on early prognostic factors after endoscopic sinus surgery: a preliminary study. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):e158-61. doi: 10.2500/ajra.2013.27.3967.
PubMed 24119597Giotakis AI, Karow EM, Scheithauer MO, Weber R, Riechelmann H. Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial. Rhinology. 2016 Dec 1;54(4):302-310. doi: 10.4193/Rhino16.026.
PubMed 27556896Kang TW, Chung JH, Cho SH, Lee SH, Kim KR, Jeong JH. The Effectiveness of Budesonide Nasal Irrigation After Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Asthma. Clin Exp Otorhinolaryngol. 2017 Mar;10(1):91-96. doi: 10.21053/ceo.2016.00220. Epub 2016 Jul 21.
PubMed 27440128Jang DW, Lachanas VA, Segel J, Kountakis SE. Budesonide nasal irrigations in the postoperative management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2013 Sep;3(9):708-11. doi: 10.1002/alr.21189. Epub 2013 Jun 17.
PubMed 23776108Oakley GM, Harvey RJ. Topical Steroids. Adv Otorhinolaryngol. 2016;79:121-30. doi: 10.1159/000445148. Epub 2016 Jul 28.
PubMed 27466854Wong KK, Marglani O, Westerberg BD, Javer AR. Systemic absorption of topical gentamicin sinus irrigation. J Otolaryngol Head Neck Surg. 2008 Jun;37(3):395-8.
PubMed 19128645
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post op Outcomes in Endoscopic Sinus Surgery Using Varying Nasal Sinus Irrigations. Saline vs. Saline and Budesonide vs Saline, Budesonide, and Culture Directed Topical Antibiotics
- ClinicalTrials.gov ID
- NCT03303677
- Acronym / sponsor ID
- IRB201701952
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- endoscopic sinus surgery, topical nasal therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn by sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 6 Oct 2017 (actual)
- 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.
The goal of the study is to compare postoperative symptom scores and endoscopy findings between in patients who receive either nasal saline rinses, saline + budesonide, and saline + topical antibiotics and budesonide following endoscopic sinus surgery.
Detailed description
The group of patients from which the study tem will recruit consists of patients referred to the University of Florida tertiary referral rhinology practice of Dr. Jeb Justice and Dr. William Collins. Patients with CRS defined by symptom, endoscopic, and radiographic criteria who are candidates for surgical intervention will be identified by the above-mentioned investigators. As part of their initial pre operative work up they will be asked to fill out SNOT-22 and RSDI surveys. As part of their surgery intraoperative cultures will be obtained from the surgically opened sinus cavities. The above radiologic, endoscopic procedures, cultures and QOL/symptoms surveys are typical in the workup of patients who present with rhinologic related problems. None of the above tests will be undertaken for the sole purpose of this study.
If the patient meets criteria, he/she will be approached by one of the investigators about participating in the research study. Information regarding the study, including the informed consent form, will be extensively discussed. If the patient agrees to take part in this study, the consent form will be provided for review and will then be signed. This consent form will be kept in a secure locked location with access given only to study staff identified in the Institutional Review Board (IRB) protocol. It will be explained to the patients that there is no obligation for them to participate in the study and that they can drop out of the study at any time without repercussions regarding their care.
If a patient elects to be a part of the study they will be randomized into one of three treatment arms. This process will be done by placing an equal number of note cards in envelopes. The note cards will contain either a "1", "2", or "3" to represent the different treatment arms. These will be placed in the envelopes, shuffled, and kept in a box in the otolaryngology clinic. At the patient's first postoperative appointment an envelope is drawn and it is documented which treatment arm the patient will be treated under.
All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm. The first treatment arm will consist of patients that are given only saline nasal irrigations to be performed twice daily. The second arm will be given a prescription for nasal saline + budesonide to be performed twice daily. The final arm will be given a prescription for nasal saline + budesonide + a culture directed topical antibiotic. These treatments are commonly used in our practice and will be obtained through the compounding pharmacies that are already in use by our practice.
Patients will be seen in follow up at 1-2 week, 3-4 week, 6-8 week, and 10-12 week follow up appointments. At each of these appointments they will undergo nasal endoscopy and debridement as is standard following endoscopic sinus surgery. They will also be asked to fill out SNOT-22 and RSDI surveys to monitor their progression.
The RSDI contains 30 questions designed to measure the patient's disease-specific status in the physical, emotional, and functional domains. The questions present the patient with symptoms and ask if there experience the symptoms never, almost never, sometimes, almost always, and always. These are scored as 0-4, with never getting a score of 0 and always getting a score of 4 for a total score range of 0-120.
The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5 where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it possibly can be. The Snot-22 has a cumulative score of 0-110.
Endoscopy findings will be scored using the Lund-Kennedy endoscopy scoring system. This system grades the endoscopic findings within the paranasal sinuses for the presence of: polyps, discharge, edema, scarring and crusting . Each side of the nasal cavity is scored separately and then combined for the total score. Polyps are scored as absent (0), present in middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0), thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal cavity a total score from 0-20 is found.
Final data will compare the pre and postoperative SNOT-22 and RSDI surveys, endoscopy findings, need for oral antibiotics, and need for oral steroids for the three treatment arms.
Cultures will be obtained for all patients during endoscopic sinus surgery as is our standard practice. During treatment patients will be treated as per standard which could include the use of oral antibiotics, oral steroids, or nasal steroid sprays as their medical condition warrants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomization into one of three treatment arms
| Arm | Type | Receives |
|---|---|---|
| Saline | Active comparator | Drug: Saline NasalPost operative endoscopic sinus surgery patients using Saline nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm. |
| Saline and budesonide | Experimental | Drug: Saline Nasal, Drug: Budesonide NasalPost operative endoscopic sinus surgery patients using saline + budesonide nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm. |
| saline, budesonide, and topical antibiotic | Experimental | Drug: Saline Nasal, Drug: Budesonide Nasal, Drug: Topical Antibacterial (Product)Post operative endoscopic sinus surgery patients using saline + budesonide + topical antibiotic nasal sinus irrigations. The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Chronic rhinosinusitis (CRS) defined by symptom, endoscopic, and radiographic criteria who are undergoing endoscopic sinus surgery
Key exclusion criteria (2 listed)
- Age <18
- endoscopic sinus surgery for reason other than CRS
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 |
|---|---|---|
| Saline Nasaltopical nasal saline rinses | Drug | Saline, Saline and budesonide, saline, budesonide, and topical antibiotic |
| Budesonide Nasalsaline + budesonide nasal saline irrigation | Drug | Saline and budesonide, saline, budesonide, and topical antibiotic |
| Topical Antibacterial (Product)Also: Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/SulfamethoxazoleThe antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole | Drug | saline, budesonide, and topical antibiotic |
Primary outcome
Change in symptom scores on Sino-nasal Outcome Test (SNOT)-22 surveys
Time frame: Up to 12 weeks post op
The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5 where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it possibly can be. The Snot-22 has a cumulative score of 0-110.
Change in symptom scores on Rhinosinusitis Disability Index (RSDI)
Time frame: Up to 12 weeks post op
The RSDI contains 30 questions designed to measure the patient's disease-specific status in the physical, emotional, and functional domains. The questions present the patient with symptoms and ask if there experience the symptoms never, almost never, sometimes, almost always, and always. These are scored as 0-4, with never getting a score of 0 and always getting a score of 4 for a total score range of 0-120.
Nasal endoscopy findings
Time frame: Up to 12 weeks post op
Lund-Kennedy endoscopy scoring system. This system grades the endoscopic findings within the paranasal sinuses for the presence of: polyps, discharge, edema, scarring and crusting. Each side of the nasal cavity is scored separately and then combined for the total score. Polyps are scored as absent (0), present in middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0), thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal cavity a total score from 0-20 is found
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Results publication: PubMed 25832968Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.
- Results publication: PubMed 26363164Rawal RB, Deal AM, Ebert CS Jr, Dhandha VH, Mitchell CA, Hang AX, Gore MR, Senior BA, Zanation AM. Post-operative budesonide irrigations for patients with polyposis: a blinded, randomized controlled trial. Rhinology. 2015 Sep;53(3):227-34. doi: 10.4193/Rhino14.196.
- Results publication: PubMed 28124652Lee VS, Davis GE. Culture-directed topical antibiotic treatment for chronic rhinosinusitis. Am J Rhinol Allergy. 2016 Nov 1;30(6):414-417. doi: 10.2500/ajra.2016.30.4380.
- Results publication: PubMed 18702902Lim M, Citardi MJ, Leong JL. Topical antimicrobials in the management of chronic rhinosinusitis: a systematic review. Am J Rhinol. 2008 Jul-Aug;22(4):381-9. doi: 10.2500/ajr.2008.22.3189.
- Results publication: PubMed 22980682Rudmik L, Smith TL. Evidence-based practice: postoperative care in endoscopic sinus surgery. Otolaryngol Clin North Am. 2012 Oct;45(5):1019-32. doi: 10.1016/j.otc.2012.06.006.
- Results publication: PubMed 22311838Portela RA, Hootnick J, McGinn J. Perioperative care in functional endoscopic sinus surgery: a survey study. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):27-33. doi: 10.1002/alr.20098. Epub 2011 Oct 24.
- Results publication: PubMed 24119597Kim ST, Sung UH, Jung JH, Paik JY, Woo JH, Cha HE, Kang IG. The effect of maxillary sinus irrigation on early prognostic factors after endoscopic sinus surgery: a preliminary study. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):e158-61. doi: 10.2500/ajra.2013.27.3967.
- Results publication: PubMed 27556896Giotakis AI, Karow EM, Scheithauer MO, Weber R, Riechelmann H. Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial. Rhinology. 2016 Dec 1;54(4):302-310. doi: 10.4193/Rhino16.026.
- Results publication: PubMed 27440128Kang TW, Chung JH, Cho SH, Lee SH, Kim KR, Jeong JH. The Effectiveness of Budesonide Nasal Irrigation After Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Asthma. Clin Exp Otorhinolaryngol. 2017 Mar;10(1):91-96. doi: 10.21053/ceo.2016.00220. Epub 2016 Jul 21.
- Results publication: PubMed 23776108Jang DW, Lachanas VA, Segel J, Kountakis SE. Budesonide nasal irrigations in the postoperative management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2013 Sep;3(9):708-11. doi: 10.1002/alr.21189. Epub 2013 Jun 17.
- Results publication: PubMed 27466854Oakley GM, Harvey RJ. Topical Steroids. Adv Otorhinolaryngol. 2016;79:121-30. doi: 10.1159/000445148. Epub 2016 Jul 28.
- Results publication: PubMed 19128645Wong KK, Marglani O, Westerberg BD, Javer AR. Systemic absorption of topical gentamicin sinus irrigation. J Otolaryngol Head Neck Surg. 2008 Jun;37(3):395-8.
- Individual participant dataSharing planned: No
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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.
Jeb Justice, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saline Nasal, Budesonide Nasal and Topical Antibacterial (Product) in people with Chronic Rhinosinusitis (Diagnosis), run by University of Florida at 1 site in United States.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in symptom scores on Sino-nasal Outcome Test (SNOT)-22 surveys (time frame: Up to 12 weeks post op). The study lists 3 primary outcomes in all. 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 NCT03303677, which also lists 12 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 30 Mar 2018.