Chronic RhinosinusitisPhase 2/3NCT03607175
Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis
A Phase 2/3 study testing Triamcinolone-impregnated CMC foam and Propel Stent in people with Chronic Rhinosinusitis and Nasal Polyps, run by Marina Boruk at 1 site in United States.
Trial summary
This is a research study to find out if an off-label use of carboxymethylcellulose foam (CMC), an absorbable nasal packing, combined with triamcinolone acetonide, a steroid, is more comfortable postoperatively for participants and is as effective in decreasing scarring, swelling and crusting after surgery than an FDA… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis, Nasal Polyps
- What is being tested?
- Triamcinolone-impregnated CMC foam and Propel Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to 30 Dec 2025
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosis of nasal polyposis and desiring surgery
Who cannot join
- A known history of intolerance to corticosteroids
- An oral steroid-dependent condition
- A history of immune deficiency
- Pre-existing narrow angle glaucoma or cataracts
- Subjects that did not complete the pre-op medical regimen described below
- Pregnant and/or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Marina Boruk, MD, 646-481-1311, marina.boruk@downstate.edu
Matthew D Adams, MD, 814-592-5634, matthew.adams@downstate.edu
About this study
Official title: Randomized Clinical Control Trial Comparing the Effects of a Steroid Eluting Implant Versus Triamcinolone-impregnated Carboxymethylcellulose Foam on the Postoperative Clinic Experience in Patients That Underwent Functional Endoscopic Surgery for Nasal Polyposis
This is a research study to find out if an off-label use of carboxymethylcellulose foam (CMC), an absorbable nasal packing, combined with triamcinolone acetonide, a steroid, is more comfortable postoperatively for participants and is as effective in decreasing scarring, swelling and crusting after surgery than an FDA approved steroid eluting implant. Anticipated sample size will be 30. Study is an intrapatient control design. Subjects will be randomly assigned to receive CMC foam with triamcinolone in one nare and the steroid-eluting implant in the other. Participants will fill out preoperative and follow-up visit surveys at 7, 14, 30 and 90 days. Subjects at each visit will also have pictures taken of the nasal cavities to be scored for later analysis. Paired t-tests will be performed for analysis.
Our primary objective is to demonstrate that triamcinolone-impregnated carboxymethylcellulose foam is noninferior to steroid-eluting implants in improving postoperative ethmoid inflammation, middle turbinate position, preventing intranasal synechiae and reducing polypoid change with objective measurement scales Our secondary objects include assessing the quality-of-life and nasal obstruction symptoms before and after functional endoscopic sinus surgery with validated SNOT-22 and NOSE questionnaires and to assess the cost-effectiveness of triamcinolone-impregnated carboxymethylcellulose foam versus steroid-eluting implant in management of CRSwNP in the early postoperative period.
The endpoints are the POSE scores, the SNOT-22 and NOSE scores at days 7, 14, 30 and 90.
- Conditions
- Chronic Rhinosinusitis, Nasal Polyps
- Being tested
- Triamcinolone-impregnated CMC foam, Propel Stent
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone-impregnated CMC foamDrug
Also called Kenalog-40
same information as included in the arm/group descriptions
Propel StentDevice
same information as included in the arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Steroid-eluting implant (Propel) | Active comparator | Mometasone furoate implant. 370ug of mometasone furoate with each application. One application to be used at the conclusion of surgery and left in place for 1 month or less depending on if it requires removal during office debridement. Receives: Device: Propel Stent |
| Triamcinolone-impregnated CMC foam | Experimental | Applied to one nostril at end of case through randomization. Experimental drug is triamcinolone-acetonide 40mg/mL. 2mL will be combined with 5mL sterile water and mixed with carboxymethylcellulose foam and placed in the nares at the conclusion of the surgery. This will only be applied once and will remain in the nares until it dissolves or 7 days. Receives: Drug: Triamcinolone-impregnated CMC foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Perioperative Sinus Endoscopy Score
The Perioperative Sinus Endoscopy score sums the combined scores determined from middle turbinate position, middle meatal status, ethmoid cavity appearance, as well as secondary sinus blockage (frontal and sphenoid). Each category is scored from 0-2, with 0 being not present, 1 as partially present, and 2 being fully present. The highest total score is 16, with scores ranging from 18-20 when the frontal and sphenoid sinuses are also included. The higher the score, the worse the status of the nasal cavity.
Comparison of the mean POSE scores for the two treatments at day 30 to determine there is noninferiority
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start24 Jul 2023 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study is an intrapatient control design, each subject will receive both interventions, one in each nostril
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marina Boruk
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center
- Responsible party
- Sponsor-investigator, Marina Boruk, State University of New York - Downstate Medical Center
- Investigators
- Marina Boruk, MD, Principal investigator, SUNY Downstate Med Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607175
- Sponsor's protocol ID
- 1161972-3
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2018
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Control Trial Comparing the Effects of a Steroid Eluting Implant Versus Triamcinolone-impregnated Carboxymethylcellulose Foam on the Postoperative Clinic Experience in Patients That Underwent Functional Endoscopic Surgery for Nasal Polyposis
- ClinicalTrials.gov ID
- NCT03607175
- Acronym / sponsor ID
- 1161972-3
- Conditions
- Chronic Rhinosinusitis, Nasal Polyps
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marina BorukUniversity, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center
- Study start
- 24 Jul 2023 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 Jul 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.
This is a research study to find out if an off-label use of carboxymethylcellulose foam (CMC), an absorbable nasal packing, combined with triamcinolone acetonide, a steroid, is more comfortable postoperatively for participants and is as effective in decreasing scarring, swelling and crusting after surgery than an FDA approved steroid eluting implant. Anticipated sample size will be 30. Study is an intrapatient control design. Subjects will be randomly assigned to receive CMC foam with triamcinolone in one nare and the steroid-eluting implant in the other. Participants will fill out preoperative and follow-up visit surveys at 7, 14, 30 and 90 days. Subjects at each visit will also have pictures taken of the nasal cavities to be scored for later analysis. Paired t-tests will be performed for analysis.
Our primary objective is to demonstrate that triamcinolone-impregnated carboxymethylcellulose foam is noninferior to steroid-eluting implants in improving postoperative ethmoid inflammation, middle turbinate position, preventing intranasal synechiae and reducing polypoid change with objective measurement scales Our secondary objects include assessing the quality-of-life and nasal obstruction symptoms before and after functional endoscopic sinus surgery with validated SNOT-22 and NOSE questionnaires and to assess the cost-effectiveness of triamcinolone-impregnated carboxymethylcellulose foam versus steroid-eluting implant in management of CRSwNP in the early postoperative period.
The endpoints are the POSE scores, the SNOT-22 and NOSE scores at days 7, 14, 30 and 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Study is an intrapatient control design, each subject will receive both interventions, one in each nostril
| Arm | Type | Receives |
|---|---|---|
| Steroid-eluting implant (Propel) | Active comparator | Device: Propel StentMometasone furoate implant. 370ug of mometasone furoate with each application. One application to be used at the conclusion of surgery and left in place for 1 month or less depending on if it requires removal during office debridement. |
| Triamcinolone-impregnated CMC foam | Experimental | Drug: Triamcinolone-impregnated CMC foamApplied to one nostril at end of case through randomization. Experimental drug is triamcinolone-acetonide 40mg/mL. 2mL will be combined with 5mL sterile water and mixed with carboxymethylcellulose foam and placed in the nares at the conclusion of the surgery. This will only be applied once and will remain in the nares until it dissolves or 7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosis of nasal polyposis and desiring surgery
Key exclusion criteria (6 listed)
- A known history of intolerance to corticosteroids
- An oral steroid-dependent condition
- A history of immune deficiency
- Pre-existing narrow angle glaucoma or cataracts
- Subjects that did not complete the pre-op medical regimen described below
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 |
|---|---|---|
| Triamcinolone-impregnated CMC foamAlso: Kenalog-40same information as included in the arm/group descriptions | Drug | Triamcinolone-impregnated CMC foam |
| Propel Stentsame information as included in the arm/group descriptions | Device | Steroid-eluting implant (Propel) |
Primary outcome
Postoperative Perioperative Sinus Endoscopy Score
Time frame: 30 days
The Perioperative Sinus Endoscopy score sums the combined scores determined from middle turbinate position, middle meatal status, ethmoid cavity appearance, as well as secondary sinus blockage (frontal and sphenoid). Each category is scored from 0-2, with 0 being not present, 1 as partially present, and 2 being fully present. The highest total score is 16, with scores ranging from 18-20 when the frontal and sphenoid sinuses are also included. The higher the score, the worse the status of the nasal cavity. Comparison of the mean POSE scores for the two treatments at day 30 to determine there is noninferiority
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
Marina Boruk, MD principal investigator
SUNY Downstate Med Ctr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Triamcinolone-impregnated CMC foam and Propel Stent in people with Chronic Rhinosinusitis and Nasal Polyps, run by Marina Boruk 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 3 inclusion and 6 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 1 Aug 2023. 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 combined 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.
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 Marina Boruk, MD (646-481-1311, marina.boruk@downstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Perioperative Sinus Endoscopy Score (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.