Chronic Sinusitis, EthmoidalPhase 3NCT03472144
Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis
A Phase 3 study testing gel loaded with steroids (momentasone), gel loaded with antibiotic (Levofloxacin) and gel loaded with both steroids and antibiotic in people with Chronic Sinusitis, Ethmoidal and Chronic Sinusitis - Ethmoidal Anterior, run by LifeBridge Health at 1 site in United States.
Trial summary
To assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis, Ethmoidal, Chronic Sinusitis - Ethmoidal Anterior, Chronic Sinusitis
- What is being tested?
- gel loaded with steroids (momentasone), gel loaded with antibiotic (Levofloxacin) and gel loaded with both steroids and antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to 7 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic sinusitis symptoms with or without polyps
- Trial of at least 2 courses of oral antimicrobial treatment without significant improvement
- CAT scan showing evidence of bilateral symmetric chronic sinusitis with or without polypss
- Endoscopic confirmation of CRS
Who cannot join
- Minor (Less than \<18 years of age).
- Pregnant and breastfeeding women.
- Allergy to specific antibiotics
- Patient currently taking oral corticosteroids.
- Patient currently taking oral antibiotics.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Alan H Shikani, MD, 410-601-6673, Ashikani@gmail.com
Hosai T Hesham, MD, 410-601-6673, hosaihesham@gmail.com
About this study
To assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected).
Read the detailed description
STUDY DESIGN This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected). Sixty patients will be included in this study. These are patients undergoing balloon sinuplasty for Chronic sinusitis with and without polyps.
As the patients will enter the study- they will be divided into Chronic sinusitis with Polyps (CRSwNP) and Chronic rhinosinusitis without polyps (CRSsNP). Each patient will be assigned in chronological order as they will join the study.
For each group, all even numbered patients will receive the active gel application on right side and all odd number patients will receive the active gel on left side.
Then patient selection for CRSwNP and CRSsNP will be as such Each group will have 3 subgroups. Subgroup 1- gel will be loaded with steroids only Subgroup 2- gel will be loaded with antibiotic (Levaquin) only Subgroup 3- gel will be loaded with both steroids and antibiotic CRSwNP group with right side gel application Subgroup 1- patient number- 1,7,13,19,25 Subgroup 2- patient number- 3,9,15,21,27 Subgroup 3- patient number- 5,11,17,23,29 CRSwNP group with left side gel application Subgroup 1- patient number- 2,8,14,20,26 Subgroup 2- patient number- 4,10,16,22,28 Subgroup 3- patient number- 6,12,18,24,30
A similar patient randomization will be done with the CRSsNP group
Surgery will consist of plain balloon sinuplasty or hybrid balloon sinuplasty with removal of ethmoids polypss using a Blakesley forceps. During surgery, and immediately after removal of diseased mucosa, 5 ccs of an active poloxamer gel containing the antibiotic or corticosteroids or both will be instilled inside the ethmoid/ maxillary sinus/frontal cavities on one side using either the balloon catheter or as a curved suction tip. The same procedure is performed in the other side, this time with instillation of plain gel without antibiotic or corticosteroids (placebo).
The purpose of the study is to assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. The assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day.
- Conditions
- Chronic Sinusitis, Ethmoidal, Chronic Sinusitis - Ethmoidal Anterior, Chronic Sinusitis, Chronic Sinusitis - Ethmoidal, Posterior, Chronic Sinusitis, Sphenoidal, Chronic Sinusitis - Frontoethmoidal
- Being tested
- gel loaded with steroids (momentasone), gel loaded with antibiotic (Levofloxacin), gel loaded with both steroids and antibiotic
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gel loaded with steroids (momentasone)Drug
Also called Momentasone
One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local corticosteroids (momentasone) after balloon sinuplasty for chronic sinusitis patients.
gel loaded with antibiotic (Levofloxacin)Drug
Also called Levofloxacin
One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients.
gel loaded with both steroids and antibioticDrug
Also called Momentasone, Levofloxacin
One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local both steroids (momentasone)and antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients.
| Study group | Role | What they receive |
|---|---|---|
| CRSwNP - Subgrp 1(Momentasone - Right) | Experimental | Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side Receives: Drug: gel loaded with steroids (momentasone) |
| CRSwNP-Subgrp 2(Levofloxacin - Right) | Experimental | Patients undergoing balloon sinuplasty with receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side Receives: Drug: gel loaded with antibiotic (Levofloxacin) |
| CRSwNP-Subgrp 3(Steroid/Antibotic Right) | Experimental | Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side Receives: Drug: gel loaded with both steroids and antibiotic |
| CRSsNP - Subgrp 1 (Momentasone Right) | Experimental | Patients undergoing ballon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side Receives: Drug: gel loaded with steroids (momentasone) |
| CRSsNP - Subgrp 2 (Levofloxacin Right) | Experimental | Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side Receives: Drug: gel loaded with antibiotic (Levofloxacin) |
| CRSsNP-Subgrp 3(Steroid/Antibiotic Right | Experimental | Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side Receives: Drug: gel loaded with both steroids and antibiotic |
| CRSwNP - Subgrp 1 (Momentasone Left) | Active comparator | Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on left side and placebo on right side Receives: Drug: gel loaded with steroids (momentasone) |
| CRSwNP - Subgrp 2 (Levofloxacin Left) | Active comparator | Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side Receives: Drug: gel loaded with antibiotic (Levofloxacin) |
| CRSwNP-Subgrp 3(Steroid/Antibiotic Left) | Active comparator | Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side Receives: Drug: gel loaded with both steroids and antibiotic |
| CRSsNP - Subgrp 1 (Momentasone Left) | Active comparator | Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only left side and placebo on right side Receives: Drug: gel loaded with steroids (momentasone) |
| CRSsNP - Subgrp 2 (Levofloxacin Left) | Active comparator | Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side Receives: Drug: gel loaded with antibiotic (Levofloxacin) |
| CRSsNP-Subgrp 3(Steroid/Antibiotic Left) | Active comparator | Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side Receives: Drug: gel loaded with both steroids and antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement reported on SNOT-22 questionnaire
Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day.
Measured: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Improvement in the Lund-Kennedy endoscopic appearance scores. Improvement in the Lund-Kennedy endoscopic appearance scores
Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day. Polyps (left, right) Edema (left, right) Discharge (left, right) Scarring (left, right) Crusting (left, right)
Scoring:
Polyps on left side - (0 absent, 1 polyps in middle meatus, 2 polyps beyond middle meatus) Polyps on right side - (0 absent, 1 polyps in middle meatus, 2 polyps beyond middle meatus) Edema, scarring and crusting on left side (0 absent, 1 mild, 2 severe) Edema, scarring and crusting on right side (0 absent, 1 mild, 2 severe) Discharge on left side (0, no discharge, 1 clear, thin discharge, 2 thick purulent discharge) Discharge on right side (0, no discharge, 1 clear, thin discharge, 2 thick purulent discharge)
Measured: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Secondary outcomes (1)
Radiological improvement of the Lund-Mackay score
Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day. Paranasal sinuses Right Left Maxillary (0, 1, 2) Anterior Ethmoid (0, 1, 2) Posterior Ethmoid (0, 1, 2) Sphenoid (0, 1, 2) Frontal (0, 1, 2)
- Ostiomeatal complex (0, 2) Total Note: 0- without abnormalities; 1- partial opacification; 2-total opacification
- 0-no obstruction; 2-obstructed
Measured: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start7 Jul 2017
- Primary completion7 Jul 2019 (estimated)
- Study completion7 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Sinusitis, EthmoidalStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan H. Shikani, MD, Principal investigator, Sinai Hospital of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472144
- Sponsor's protocol ID
- 2397
- Status last verified
- Mar 2018
- First submitted
- 15 Dec 2017
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided so far
Publications
Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ, Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith TL, Witsell DL. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3 Suppl):S1-31. doi: 10.1016/j.otohns.2007.06.726.
PubMed 17761281Vaughan WC. Review of balloon sinuplasty. Curr Opin Otolaryngol Head Neck Surg. 2008 Feb;16(1):2-9. doi: 10.1097/MOO.0b013e3282f5e955.
PubMed 18197013Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.
PubMed 17903570Alves DA, Machado D, Melo A, Pereira RF, Severino P, de Hollanda LM, Araujo DR, Lancellotti M. Preparation of Thermosensitive Gel for Controlled Release of Levofloxacin and Their Application in the Treatment of Multidrug-Resistant Bacteria. Biomed Res Int. 2016;2016:9702129. doi: 10.1155/2016/9702129. Epub 2016 Sep 5.
PubMed 27689094Li C, Gu J, Mao X, Ao H, Yang X. Preparation of levofloxacin thermo-sensitive gel and clinical application in the treatment of suppurative otitis media. Acta Otolaryngol. 2014 May;134(5):468-74. doi: 10.3109/00016489.2013.878473. Epub 2014 Mar 6.
PubMed 24597493Dumortier G, Grossiord JL, Agnely F, Chaumeil JC. A review of poloxamer 407 pharmaceutical and pharmacological characteristics. Pharm Res. 2006 Dec;23(12):2709-28. doi: 10.1007/s11095-006-9104-4. Epub 2006 Nov 11.
PubMed 17096184Shikani AH, Chahine KA, Alqudah MA. The rhinotopic protocol for chronic refractory rhinosinusitis: how we do it. Clin Otolaryngol. 2010 Aug;35(4):329-32. doi: 10.1111/j.1749-4486.2010.02157.x. No abstract available.
PubMed 20738346Shikani AH, Chahine KA, Alqudah MA. Rhinotopic therapy for refractory chronic rhinosinusitis: a study of 20 cases. Ear Nose Throat J. 2014 Apr-May;93(4-5):E48-54.
PubMed 24817242Shikani AH, Kourelis K, Rohayem Z, Basaraba RJ, Leid JG. Topical gel therapy for sinonasal polyposis in Samter's triad: preliminary report. Ann Otol Rhinol Laryngol. 2012 Nov;121(11):719-24. doi: 10.1177/000348941212101104.
PubMed 23193904
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis
- ClinicalTrials.gov ID
- NCT03472144
- Acronym / sponsor ID
- 2397
- Conditions
- Chronic Sinusitis, Ethmoidal, Chronic Sinusitis - Ethmoidal Anterior, Chronic Sinusitis, Chronic Sinusitis - Ethmoidal, Posterior, Chronic Sinusitis, Sphenoidal, Chronic Sinusitis - Frontoethmoidal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 7 Jul 2019 (estimated)
- Study completion
- 7 Dec 2019 (estimated)
- First posted
- 21 Mar 2018 (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.
To assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected).
Detailed description
STUDY DESIGN This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected). Sixty patients will be included in this study. These are patients undergoing balloon sinuplasty for Chronic sinusitis with and without polyps.
As the patients will enter the study- they will be divided into Chronic sinusitis with Polyps (CRSwNP) and Chronic rhinosinusitis without polyps (CRSsNP). Each patient will be assigned in chronological order as they will join the study.
For each group, all even numbered patients will receive the active gel application on right side and all odd number patients will receive the active gel on left side.
Then patient selection for CRSwNP and CRSsNP will be as such Each group will have 3 subgroups. Subgroup 1- gel will be loaded with steroids only Subgroup 2- gel will be loaded with antibiotic (Levaquin) only Subgroup 3- gel will be loaded with both steroids and antibiotic CRSwNP group with right side gel application Subgroup 1- patient number- 1,7,13,19,25 Subgroup 2- patient number- 3,9,15,21,27 Subgroup 3- patient number- 5,11,17,23,29 CRSwNP group with left side gel application Subgroup 1- patient number- 2,8,14,20,26 Subgroup 2- patient number- 4,10,16,22,28 Subgroup 3- patient number- 6,12,18,24,30
A similar patient randomization will be done with the CRSsNP group
Surgery will consist of plain balloon sinuplasty or hybrid balloon sinuplasty with removal of ethmoids polypss using a Blakesley forceps. During surgery, and immediately after removal of diseased mucosa, 5 ccs of an active poloxamer gel containing the antibiotic or corticosteroids or both will be instilled inside the ethmoid/ maxillary sinus/frontal cavities on one side using either the balloon catheter or as a curved suction tip. The same procedure is performed in the other side, this time with instillation of plain gel without antibiotic or corticosteroids (placebo).
The purpose of the study is to assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. The assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
- Model description
- This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected).
| Arm | Type | Receives |
|---|---|---|
| CRSwNP - Subgrp 1(Momentasone - Right) | Experimental | Drug: gel loaded with steroids (momentasone)Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side |
| CRSwNP-Subgrp 2(Levofloxacin - Right) | Experimental | Drug: gel loaded with antibiotic (Levofloxacin)Patients undergoing balloon sinuplasty with receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side |
| CRSwNP-Subgrp 3(Steroid/Antibotic Right) | Experimental | Drug: gel loaded with both steroids and antibioticPatients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side |
| CRSsNP - Subgrp 1 (Momentasone Right) | Experimental | Drug: gel loaded with steroids (momentasone)Patients undergoing ballon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side |
| CRSsNP - Subgrp 2 (Levofloxacin Right) | Experimental | Drug: gel loaded with antibiotic (Levofloxacin)Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side |
| CRSsNP-Subgrp 3(Steroid/Antibiotic Right | Experimental | Drug: gel loaded with both steroids and antibioticPatients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side |
| CRSwNP - Subgrp 1 (Momentasone Left) | Active comparator | Drug: gel loaded with steroids (momentasone)Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on left side and placebo on right side |
| CRSwNP - Subgrp 2 (Levofloxacin Left) | Active comparator | Drug: gel loaded with antibiotic (Levofloxacin)Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side |
| CRSwNP-Subgrp 3(Steroid/Antibiotic Left) | Active comparator | Drug: gel loaded with both steroids and antibioticPatients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side |
| CRSsNP - Subgrp 1 (Momentasone Left) | Active comparator | Drug: gel loaded with steroids (momentasone)Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only left side and placebo on right side |
| CRSsNP - Subgrp 2 (Levofloxacin Left) | Active comparator | Drug: gel loaded with antibiotic (Levofloxacin)Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side |
| CRSsNP-Subgrp 3(Steroid/Antibiotic Left) | Active comparator | Drug: gel loaded with both steroids and antibioticPatients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic sinusitis symptoms with or without polyps
- Trial of at least 2 courses of oral antimicrobial treatment without significant improvement
- CAT scan showing evidence of bilateral symmetric chronic sinusitis with or without polypss
- Endoscopic confirmation of CRS
Key exclusion criteria (5 listed)
- Minor (Less than \<18 years of age).
- Pregnant and breastfeeding women.
- Allergy to specific antibiotics
- Patient currently taking oral corticosteroids.
- Patient currently taking oral antibiotics.
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 |
|---|---|---|
| gel loaded with steroids (momentasone)Also: MomentasoneOne of the purpose of this study is to evaluate the efficacy of a gel that actively releases local corticosteroids (momentasone) after balloon sinuplasty for chronic sinusitis patients. | Drug | CRSsNP - Subgrp 1 (Momentasone Left), CRSsNP - Subgrp 1 (Momentasone Right), CRSwNP - Subgrp 1 (Momentasone Left), CRSwNP - Subgrp 1(Momentasone - Right) |
| gel loaded with antibiotic (Levofloxacin)Also: LevofloxacinOne of the purpose of this study is to evaluate the efficacy of a gel that actively releases local antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients. | Drug | CRSsNP - Subgrp 2 (Levofloxacin Left), CRSsNP - Subgrp 2 (Levofloxacin Right), CRSwNP - Subgrp 2 (Levofloxacin Left), CRSwNP-Subgrp 2(Levofloxacin - Right) |
| gel loaded with both steroids and antibioticAlso: Momentasone, LevofloxacinOne of the purpose of this study is to evaluate the efficacy of a gel that actively releases local both steroids (momentasone)and antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients. | Drug | CRSsNP-Subgrp 3(Steroid/Antibiotic Left), CRSsNP-Subgrp 3(Steroid/Antibiotic Right, CRSwNP-Subgrp 3(Steroid/Antibiotic Left), CRSwNP-Subgrp 3(Steroid/Antibotic Right) |
Primary outcome
Clinical improvement reported on SNOT-22 questionnaire
Time frame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day.
Improvement in the Lund-Kennedy endoscopic appearance scores. Improvement in the Lund-Kennedy endoscopic appearance scores
Time frame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day. Polyps (left, right) Edema (left, right) Discharge (left, right) Scarring (left, right) Crusting (left, right) Scoring: Polyps on left side - (0 absent, 1 polyps in middle meatus, 2 polyps beyond middle meatus) Polyps on right side - (0 absent, 1 polyps in middle meatus, 2 polyps beyond middle meatus) Edema, scarring and crusting on left side (0 absent, 1 mild, 2 severe) Edema, scarring and crusting on right side (0 absent, 1 mild, 2 severe) Discharge on left side (0, no discharge, 1 clear, thin discharge, 2 thick purulent discharge) Discharge on right side (0, no discharge, 1 clear, thin discharge, 2 thick purulent discharge)
1 secondary outcome
Radiological improvement of the Lund-Mackay score
Time frame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Background: PubMed 17761281Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ, Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith TL, Witsell DL. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3 Suppl):S1-31. doi: 10.1016/j.otohns.2007.06.726.
- Background: PubMed 18197013Vaughan WC. Review of balloon sinuplasty. Curr Opin Otolaryngol Head Neck Surg. 2008 Feb;16(1):2-9. doi: 10.1097/MOO.0b013e3282f5e955.
- Background: PubMed 17903570Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.
- Background: PubMed 27689094Alves DA, Machado D, Melo A, Pereira RF, Severino P, de Hollanda LM, Araujo DR, Lancellotti M. Preparation of Thermosensitive Gel for Controlled Release of Levofloxacin and Their Application in the Treatment of Multidrug-Resistant Bacteria. Biomed Res Int. 2016;2016:9702129. doi: 10.1155/2016/9702129. Epub 2016 Sep 5.
- Background: PubMed 24597493Li C, Gu J, Mao X, Ao H, Yang X. Preparation of levofloxacin thermo-sensitive gel and clinical application in the treatment of suppurative otitis media. Acta Otolaryngol. 2014 May;134(5):468-74. doi: 10.3109/00016489.2013.878473. Epub 2014 Mar 6.
- Background: PubMed 17096184Dumortier G, Grossiord JL, Agnely F, Chaumeil JC. A review of poloxamer 407 pharmaceutical and pharmacological characteristics. Pharm Res. 2006 Dec;23(12):2709-28. doi: 10.1007/s11095-006-9104-4. Epub 2006 Nov 11.
- Results publication: PubMed 20738346Shikani AH, Chahine KA, Alqudah MA. The rhinotopic protocol for chronic refractory rhinosinusitis: how we do it. Clin Otolaryngol. 2010 Aug;35(4):329-32. doi: 10.1111/j.1749-4486.2010.02157.x. No abstract available.
- Results publication: PubMed 24817242Shikani AH, Chahine KA, Alqudah MA. Rhinotopic therapy for refractory chronic rhinosinusitis: a study of 20 cases. Ear Nose Throat J. 2014 Apr-May;93(4-5):E48-54.
- Results publication: PubMed 23193904Shikani AH, Kourelis K, Rohayem Z, Basaraba RJ, Leid JG. Topical gel therapy for sinonasal polyposis in Samter's triad: preliminary report. Ann Otol Rhinol Laryngol. 2012 Nov;121(11):719-24. doi: 10.1177/000348941212101104.
- Individual participant dataSharing planned: Undecided. undecided so far
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.
Alan H. Shikani, MD principal investigator
Sinai Hospital of Baltimore
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 gel loaded with steroids (momentasone), gel loaded with antibiotic (Levofloxacin) and gel loaded with both steroids and antibiotic in people with Chronic Sinusitis, Ethmoidal and Chronic Sinusitis - Ethmoidal Anterior, run by LifeBridge Health 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 4 inclusion and 5 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 21 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan H. Shikani, MD (410-601-6673, ashikani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement reported on SNOT-22 questionnaire (time frame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.). The study lists 2 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 NCT03472144, which also lists 9 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 21 Mar 2018.