Nasal PolypsPhase 1/2NCT01222871
Treatment of Early Nasal Polyposis With Topical Triamcinolone
A Phase 1/2 study testing Triamcinolone and Saline soaked sponge in people with Nasal Polyps, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of intranasal Triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- Triamcinolone and Saline soaked sponge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age > 18 years
- Patients with early nasal polyposis
Who cannot join
- Age < 18 years
- Patients with active sinus infections
- Patients on long term steroids
- Allergy or sensitivity to steroids
- Patients with Antrochoanal polyps
- Patients who received topical steroids by bio-resorbable sponge or oral steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Elizabeth's Medical Center, 736 Cambridge St
Brighton, Massachusetts, 02135
About this study
The purpose of this study is to compare the effectiveness of intranasal Triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis.
Read the detailed description
nasopore, a bio-absorbable nasal dressing, may offer an alternative route of sustained steroid drug delivery. The use of topical targeted intranasal steroids may prevent the routine adverse effects of oral steroids while maintaining the same therapeutic / clinical efficacy.
- Conditions
- Nasal Polyps
- Being tested
- Triamcinolone, Saline soaked sponge
- Keywords
- Treatment
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
Also called Kenalog (40)
Triamcinolone soaked nasopore dressing
Saline soaked spongeDrug
saline soaked sponge
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone | Experimental | Triamcinolone soaked nasopore dressing Receives: Drug: Triamcinolone |
| Control Group | Placebo comparator | Saline soaked sponge Receives: Drug: Saline soaked sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Endoscopic Exam Findings .
nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant.
Measured: 2 weeks, 6 weeks, 12 weeks were not collected from any participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionAug 2012
Why it stopped: not enough particpants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasal PolypsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients will be randomized into 2 study groups, experimental and control.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Catalano, Steward St. Elizabeth's Medical Center of Boston, Inc.
- Investigators
- Peter Catalano, MD, Study director, Steward St. Elizabeth's Medical Center of Boston, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222871
- Sponsor's protocol ID
- 00540
- Status last verified
- Jun 2018
- First submitted
- 14 Oct 2010
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Early Nasal Polyposis With Topical Triamcinolone
- ClinicalTrials.gov ID
- NCT01222871
- Acronym / sponsor ID
- 00540
- Conditions
- Nasal Polyps
- Keywords
- Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough particpants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Posted 28 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of intranasal Triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis.
Detailed description
nasopore, a bio-absorbable nasal dressing, may offer an alternative route of sustained steroid drug delivery. The use of topical targeted intranasal steroids may prevent the routine adverse effects of oral steroids while maintaining the same therapeutic / clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized into 2 study groups, experimental and control.
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone | Experimental | Drug: TriamcinoloneTriamcinolone soaked nasopore dressing |
| Control Group | Placebo comparator | Drug: Saline soaked spongeSaline soaked sponge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Patients with early nasal polyposis
Key exclusion criteria (6 listed)
- Age < 18 years
- Patients with active sinus infections
- Patients on long term steroids
- Allergy or sensitivity to steroids
- Patients with Antrochoanal polyps
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 |
|---|---|---|
| TriamcinoloneAlso: Kenalog (40)Triamcinolone soaked nasopore dressing | Drug | Triamcinolone |
| Saline soaked spongesaline soaked sponge | Drug | Control Group |
Primary outcome
Nasal Endoscopic Exam Findings .
Time frame: 2 weeks, 6 weeks, 12 weeks were not collected from any participant.
nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Peter Catalano, MD study director
Steward St. Elizabeth's Medical Center of Boston, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Triamcinolone and Saline soaked sponge in people with Nasal Polyps, run by Steward St. Elizabeth's Medical Center of Boston, Inc. 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 2 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: stopped early, as of the sponsor's last update on 28 Jun 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 28 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Nasal Endoscopic Exam Findings . (time frame: 2 weeks, 6 weeks, 12 weeks were not collected from any participant.). 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 28 Jun 2018.