Chronic Rhinosinusitis Without Nasal Polyps
Conditions
Keywords
Sinus disease, Sinonasal complaints, Chronic sinusitis, Nasal polyps, Chronic rhinosinusitis without nasal polyps, Glucocorticoids, Prednisone, Topical mometasone, Anti-inflammatory agents
Brief summary
The purpose of this study is to determine the most effective route to administer steroids to patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with nasal polyps (CRSsNP). The investigators would like to better understand whether orally administered steroids results in superior results when compared with nasally sprayed steroids. The investigators propose to test the hypothesis that for patients with radiographically proven CRSsNP, routine medical therapy consisting of a short course of systemic corticosteroids is superior to topical corticosteroids for relieving inflammation and the symptoms of CRS.
Detailed description
Chronic sinus infections (chronic sinusitis or CRS) are common conditions that affect millions of Americans. While this is a common disorder, medical treatments for this condition vary a lot and little is known how and why different treatments work in some individuals and not in others. Some physicians commonly utilize a course of oral steroid therapy similar to treatment of inflammatory conditions including asthma and arthritis. Other physicians feel that oral steroids are not more effective than nasal steroid sprays in reducing inflammation and prefer prescribing nasal steroids. There is no conclusive data as to whether oral or sprayed nasal steroids are more effective in providing long-term benefit to patients. Nasal steroids are FDA approved to treat some types of chronic sinusitis but oral steroids are FDA approved medications that are used to treat inflammatory conditions but is not specifically indicated for chronic sinusitis and thus should be regarded as investigational drug. The purpose of this research study is to better understand whether orally administered steroids results in superior results when compared with nasally sprayed steroids. The investigators will compare patients with chronic sinusitis who are first treated with antibiotics and oral steroids, and compare them to chronic sinusitis patients who receive antibiotics and nasally sprayed steroid therapy.
Interventions
DRUGPrednisone
Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead Antihistamines if an appropriate history of atopy is obtained Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study
DRUGTopical mometasone
Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead Antihistamines if an appropriate history of atopy is obtained Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the Taskforce on Rhinosinusitis. 2. They have a CT-scan in our clinic or have a viewable recent (\< 3weeks prior to clinic visit) CT-scan with a Lund Mckay score of 6 or greater. A Lund Mckay score of 6 or greater is felt to be indicative of at least moderate CRS. 3. They do not have nasal polyps on initial clinic nasal endoscopy 4. They are willing to participate in a clinical study 5. They are between the ages of 18 to 80.
Exclusion criteria
1. They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded. 2. They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded. 3. They have been treated with a \> 3 week course of antibiotics and/or systemic steroids will also be excluded. 4. They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis. 5. They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants. 6. They have nasal polyps on physical exam. 7. They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging. 8. They have a Lund-Mckay score on CT scan of \< 6 9. They are \< 18 or \> 80 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SNOT-22 Questionnaire | 4-6 weeks and 3 months after initiation of treatment | The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (nasal obstruction and loss of smell and taste) ranked from 0 (not a problem) to 5 (problem as bad as it can be). Min score= 0, Max score= 110 (worst possible problem on all symptoms) Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lund-McKay Score From CT Scan | 4-6 weeks and 3 months after initiation of treatment | Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses. |
| Taskforce Symptom Inventory | 4-6 weeks and 3 months after initiation of treatment | Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS. |
| Medication Side-effect and Compliance Inventory | 4-6 weeks and 3 months after initiation of treatment | The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study. |
Countries
United States
Participant flow
Recruitment details
Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.
Participants by arm
| Arm | Count |
|---|---|
| Prednisone Oral steroid medication
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study | 4 |
| Topical Mometasone Topical steroid medication
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study. | 5 |
| Total | 9 |
Baseline characteristics
| Characteristic | Prednisone | Topical Mometasone | Total |
|---|---|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 16.5 | 45.9 years STANDARD_DEVIATION 11.5 | 46.3 years STANDARD_DEVIATION 14.3 |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
Primary
SNOT-22 Questionnaire
The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (nasal obstruction and loss of smell and taste) ranked from 0 (not a problem) to 5 (problem as bad as it can be). Min score= 0, Max score= 110 (worst possible problem on all symptoms) Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.
Time frame: 4-6 weeks and 3 months after initiation of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prednisone | SNOT-22 Questionnaire | 4-6 WEEKS | 45.75 units on a scale | Standard Error 6.7 |
| Prednisone | SNOT-22 Questionnaire | 3 MONTHS | 49 units on a scale | Standard Error 9.3 |
| Topical Mometasone | SNOT-22 Questionnaire | 4-6 WEEKS | 34.4 units on a scale | Standard Error 6 |
| Topical Mometasone | SNOT-22 Questionnaire | 3 MONTHS | 34.4 units on a scale | Standard Error 8.36 |
Secondary
Lund-McKay Score From CT Scan
Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.
Time frame: 4-6 weeks and 3 months after initiation of treatment
Population: Only a few of the patients were able to return for the follow up CT scan, therefore this measure was not analyzed.
Secondary
Medication Side-effect and Compliance Inventory
The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.
Time frame: 4-6 weeks and 3 months after initiation of treatment
Population: Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisone | Medication Side-effect and Compliance Inventory | 0 Participants |
| Topical Mometasone | Medication Side-effect and Compliance Inventory | 0 Participants |
Secondary
Taskforce Symptom Inventory
Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.
Time frame: 4-6 weeks and 3 months after initiation of treatment
Population: Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisone | Taskforce Symptom Inventory | 0 Participants |
| Topical Mometasone | Taskforce Symptom Inventory | 0 Participants |