Chronic Rhinosinusitis, PolypsNCT03144375
QOL Outcomes in CRS With Polyps
A study testing Medical optimization and education in people with Chronic Rhinosinusitis, Polyps, run by University of Miami at 1 site in United States.
Trial summary
Chronic rhinosinusits (CRS) is common disease with reports of prevalence ranging from 4-16% in the western population. The main outcome measure for chronic disease treatment, such as CRS, is quality of life. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis, Polyps
- What is being tested?
- Medical optimization and education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Oct 2016
- Phase
- Interventional
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with Rhinosinusitis with polyps who have had appropriate treatment qualifying them for surgery and are good surgical candidates
Who cannot join
- Cystic fibrosis, Cilia disorders, other specialized forms of sinus disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Outcomes After Peri-operative Optimization and Standard Surgical Treatment or Standard of Care Surgical Treatment in Patients Who Have Chronic Rhinosinusitis With Polyposis.
Chronic rhinosinusits (CRS) is common disease with reports of prevalence ranging from 4-16% in the western population. The main outcome measure for chronic disease treatment, such as CRS, is quality of life. Several large multi-institutional studies have shown that improvement in disease specific Quality of life was greater in patients who had surgery for their CRS with polyps. The timing of surgery in these patients has not been well studied but it is generally agreed upon that surgical candidates much had failed medical management. The definition of medical management varies greatly but usually includes some form of nasal or oral steroids and a prolonged ( >10 days) course of antibiotics.
Another known way to improve QOL is through education and individualized optimization. This has been utilized successfully in other fields with good success and improved QOL. Similar studies looking at combining non-surgical optimization and education have not been performed in CRS. This study aims to address this potential area for improvement in patient quality of life outcomes. Investigators plan to assess the potential role for pre-operative non-surgical medical and educational optimization in CRS standard of care treatment.
- Conditions
- Chronic Rhinosinusitis, Polyps
- Being tested
- Medical optimization and education, Standard of Care sinus surgery
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical optimization and educationOther
Medical treatment and education about the sinusitis disease process prior to surgery as compared to baseline surgical and treatment counseling
Standard of Care sinus surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Medical Optimization | Active comparator | Medical treatment and education x 4 months, re- eval at 4 months and possible cross-over to surgery Receives: Other: Medical optimization and education; Procedure: Standard of Care sinus surgery |
| Surgical treatment | Active comparator | Surgical treatment up front Receives: Procedure: Standard of Care sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT-22
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startDec 2015
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: inability to promptly see local allergists as part of medical maximization which lead to delays in care for these patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corinna Levine, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144375
- Sponsor's protocol ID
- 20151068
- Status last verified
- May 2017
- First submitted
- 3 May 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes After Peri-operative Optimization and Standard Surgical Treatment or Standard of Care Surgical Treatment in Patients Who Have Chronic Rhinosinusitis With Polyposis.
- ClinicalTrials.gov ID
- NCT03144375
- Acronym / sponsor ID
- 20151068
- Conditions
- Chronic Rhinosinusitis, Polyps
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to promptly see local allergists as part of medical maximization which lead to delays in care for these patients
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 May 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.
Chronic rhinosinusits (CRS) is common disease with reports of prevalence ranging from 4-16% in the western population. The main outcome measure for chronic disease treatment, such as CRS, is quality of life. Several large multi-institutional studies have shown that improvement in disease specific Quality of life was greater in patients who had surgery for their CRS with polyps. The timing of surgery in these patients has not been well studied but it is generally agreed upon that surgical candidates much had failed medical management. The definition of medical management varies greatly but usually includes some form of nasal or oral steroids and a prolonged ( >10 days) course of antibiotics.
Another known way to improve QOL is through education and individualized optimization. This has been utilized successfully in other fields with good success and improved QOL. Similar studies looking at combining non-surgical optimization and education have not been performed in CRS. This study aims to address this potential area for improvement in patient quality of life outcomes. Investigators plan to assess the potential role for pre-operative non-surgical medical and educational optimization in CRS standard of care treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Optimization | Active comparator | Other: Medical optimization and education, Procedure: Standard of Care sinus surgeryMedical treatment and education x 4 months, re- eval at 4 months and possible cross-over to surgery |
| Surgical treatment | Active comparator | Procedure: Standard of Care sinus surgerySurgical treatment up front |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with Rhinosinusitis with polyps who have had appropriate treatment qualifying them for surgery and are good surgical candidates
Key exclusion criteria (1 listed)
- Cystic fibrosis, Cilia disorders, other specialized forms of sinus disease
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 |
|---|---|---|
| Medical optimization and educationMedical treatment and education about the sinusitis disease process prior to surgery as compared to baseline surgical and treatment counseling | Other | Medical Optimization |
| Standard of Care sinus surgery | Procedure or surgery | Medical Optimization, Surgical treatment |
Primary outcome
SNOT-22
Time frame: 4 months
Results and safety
The study was stopped early (reason given: inability to promptly see local allergists as part of medical maximization which lead to delays in care for these patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical optimization and education in people with Chronic Rhinosinusitis, Polyps, run by University of Miami 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 1 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 8 May 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 was stopped early (reason given: inability to promptly see local allergists as part of medical maximization which lead to delays in care for these patients). Results are not available in the source record.
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?
SNOT-22 (time frame: 4 months). 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 8 May 2017.