Size of Nasal PolypsdexamethasoneNCT01777906
Study of the Efficacy of Topical Nasal Steroids Patients With Nasal Polyps
An observational study of Size of Nasal Polyps and Control of Symptoms, run by Loma Linda University at 1 site in United States.
Trial summary
Topical nasal steroid sprays are the mainstream treatment for patients with nasal polyps. Polyps tend to recur after surgery and topical nasal steroid sprays are used as the primary medical management to prevent continued growth. More recently high dose topical nasal steroid sprays are used. Read more about this study
- Who is it for?
- Ages 17 to 85 years
- Conditions the study is for
- Size of Nasal Polyps, Control of Symptoms
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2017
- Phase
- Observational
- 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 17 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group 1 - will be given fluticasone nasal spray Group 2- will be given dexamethasone nasal spray The 2 groups will be compared in terms of symptom control and polyp size
Who may be able to join
- Subjects with nasal polyps who have had sinus surgery at least 3 months prior to enrollment.
Who cannot join
- Allergy to steroids
- Glaucoma
- Cataracts
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinus and Allergy Center
Loma Linda, California, 92373
About this study
Official title: Comparison of Topical Nasal Steroids in Postoperative Sinus Patients With Nasal Polyps
Topical nasal steroid sprays are the mainstream treatment for patients with nasal polyps. Polyps tend to recur after surgery and topical nasal steroid sprays are used as the primary medical management to prevent continued growth. More recently high dose topical nasal steroid sprays are used. It is thought that the higher dose will penetrate the sinus cavities at an increased dose and will allow for greater control of polyp growth. Safety studies have been performed which have shown no suppression of the pituitary axis with long term high dose topical steroid or changes in intraocular pressure. However, studies in efficacy are limited despite their widespread use. The objective of this study will be to compare the effectiveness of two topical nasal steroid sprays in patients with recurrent nasal polyps.
Read the detailed description
Recruitment plan- Patients with nasal polyps who have had sinus surgery at least 3 months prior and documented nasal polyps by endoscopy will be prospectively recruited. This will be a randomized blinded study. Patients will be randomized into two groups- group 1 will received topical fluticasone and group 2 will receive topical dexamethasone spray to the nasal cavity. The investigator will be blinded as to which group the subjects are placed in. The medications will be given out from the inland compounding pharmacy located at 24747 Redlands Blvd, in Loma Linda.
Procedures
- At the time of enrollment nasal endoscopy will be performed to confirm the diagnosis of nasal polyps and to grade the size of the polyps. Polyp size will be graded by the following scale: 0- no polyps, 1- polypoid mucosa, 2- polyps within sinus not occluding ostium, 3- polyps occluding ostium filling nasal cavity
- Subjects will be asked to fill out a SNOT 20 survey before the start of therapy.
- Subjects will be randomized into 2 groups by the flip of a coin. The investigator will be blinded to which group the subject is placed in. The pharmacist (Raylene Mote, Inland compounding pharmacy) who compounds the medications will be the only one aware of which medication was given.
- Subjects will pick up their medication at the inland compounding pharmacy and will be instructed to use the nasal spray- 2 sprays twice a day for 6 weeks.
- After 6 weeks the subjects will return to the office for repeat nasal endoscopy and will be asked to fill out a SNOT 20 survey.
- Continued therapy of the nasal steroid spray will be at the discretion of the physician. If subjects do not appear to be responding the nasal steroid spray the medication will be altered as deemed medically necessary.
- Conditions
- Size of Nasal Polyps, Control of Symptoms
- Keywords
- nasal polyps, nasal steriod sprays
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone | Fluticasone nasal spray will be given 2 sprays twice a day for 6 weeks. | |
| Dexamethasone sodium phosphate 0.032% | Dexamethasone 0.032% nasal spray will be given at a dose of 2 sprays twice a day for 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of topical nasal steroids in postoperative sinus patients
Primary outcome will be symptomatic improvement measured by the SNOT 20 survey and physical size of polyps as measured by nasal endoscopy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Size of Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Seiberling, MD, Loma Linda University
- Investigators
- Kristin Seiberling, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777906
- Sponsor's protocol ID
- 5130043
- Acronym
- dexamethasone
- Status last verified
- Mar 2017
- First submitted
- 24 Jan 2013
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Nasal Steroids in Postoperative Sinus Patients With Nasal Polyps
- ClinicalTrials.gov ID
- NCT01777906
- Acronym / sponsor ID
- dexamethasone / 5130043
- Conditions
- Size of Nasal Polyps, Control of Symptoms
- Keywords
- nasal polyps, nasal steriod sprays
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Topical nasal steroid sprays are the mainstream treatment for patients with nasal polyps. Polyps tend to recur after surgery and topical nasal steroid sprays are used as the primary medical management to prevent continued growth. More recently high dose topical nasal steroid sprays are used. It is thought that the higher dose will penetrate the sinus cavities at an increased dose and will allow for greater control of polyp growth. Safety studies have been performed which have shown no suppression of the pituitary axis with long term high dose topical steroid or changes in intraocular pressure. However, studies in efficacy are limited despite their widespread use. The objective of this study will be to compare the effectiveness of two topical nasal steroid sprays in patients with recurrent nasal polyps.
Detailed description
Recruitment plan- Patients with nasal polyps who have had sinus surgery at least 3 months prior and documented nasal polyps by endoscopy will be prospectively recruited. This will be a randomized blinded study. Patients will be randomized into two groups- group 1 will received topical fluticasone and group 2 will receive topical dexamethasone spray to the nasal cavity. The investigator will be blinded as to which group the subjects are placed in. The medications will be given out from the inland compounding pharmacy located at 24747 Redlands Blvd, in Loma Linda.
Procedures
- At the time of enrollment nasal endoscopy will be performed to confirm the diagnosis of nasal polyps and to grade the size of the polyps. Polyp size will be graded by the following scale: 0- no polyps, 1- polypoid mucosa, 2- polyps within sinus not occluding ostium, 3- polyps occluding ostium filling nasal cavity
- Subjects will be asked to fill out a SNOT 20 survey before the start of therapy.
- Subjects will be randomized into 2 groups by the flip of a coin. The investigator will be blinded to which group the subject is placed in. The pharmacist (Raylene Mote, Inland compounding pharmacy) who compounds the medications will be the only one aware of which medication was given.
- Subjects will pick up their medication at the inland compounding pharmacy and will be instructed to use the nasal spray- 2 sprays twice a day for 6 weeks.
- After 6 weeks the subjects will return to the office for repeat nasal endoscopy and will be asked to fill out a SNOT 20 survey.
- Continued therapy of the nasal steroid spray will be at the discretion of the physician. If subjects do not appear to be responding the nasal steroid spray the medication will be altered as deemed medically necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone | – | –Fluticasone nasal spray will be given 2 sprays twice a day for 6 weeks. |
| Dexamethasone sodium phosphate 0.032% | – | –Dexamethasone 0.032% nasal spray will be given at a dose of 2 sprays twice a day for 6 weeks. |
Who may qualify
- Ages
- 17 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group 1 - will be given fluticasone nasal spray Group 2- will be given dexamethasone nasal spray The 2 groups will be compared in terms of symptom control and polyp size
Key inclusion criteria (1 listed)
- Subjects with nasal polyps who have had sinus surgery at least 3 months prior to enrollment.
Key exclusion criteria (3 listed)
- Allergy to steroids
- Glaucoma
- Cataracts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of topical nasal steroids in postoperative sinus patients
Time frame: 1 year
Primary outcome will be symptomatic improvement measured by the SNOT 20 survey and physical size of polyps as measured by nasal endoscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
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.
Kristin Seiberling, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Size of Nasal Polyps and Control of Symptoms, run by Loma Linda University 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 3 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: finished, as of the sponsor's last update on 27 Mar 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of topical nasal steroids in postoperative sinus patients (time frame: 1 year). 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 27 Mar 2017.