Sinusitis, Chronic
Conditions
Keywords
steroid, recurrence, smell, biomarker, endoscopy
Brief summary
This study investigate the additive effect of systemic postoperative steroids in patients with chronic rhinosinusitis (CRSwNP). All patients receive a functional endoscopic sinus surgery (FESS) followed by topical steroid spray for 3 months. Postoperatively, patients will be randomized to either an additional systemic steroid or a placebo for 1 month. Patients will be followed for 2 years. Effect on Nasal Polyp score (NPS), Lund-Kennedy-Score (LKS), recurrence rates, smell scores, Rhinosinusitis Disability Index (RSDI), Short-Form 36 (SF-36) and mucus/serum biomarkers will be measured.
Interventions
DRUGSystemic Steroid (Prednisolone)
Systemic steroids (Prednisolone) additive to topical steroids (Mometasone fuorate) in a postoperative setting after FESS
OTHERPlacebo
Placebo additive to topical steroids in a postoperative setting after FESS
Sponsors
Friedrich-Alexander-Universität Erlangen-Nürnberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CRSwNP * refractory to medical therapy * no previous sinus surgery * Lund-Kennedy-Score ≥ 1 * Lund-Mackay-Score ≥ 10
Exclusion criteria
* ciliary impairment * autoimmune disease * cystic fibrosis * immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Polyp Score (NPS) | first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) | Each nostril will be assessed separately. The highest score will be graded. Each nostril will be scored from 0-4 (0=no polyps, 1=polyps confined to the middle meatus, 3=polyps extending beyond middle meatus, 4=large polyps causing almost complete nasal obstruction) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smell Scores | first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) | Sniffing Sticks Screening-16 test (forced choice), graded from 0-16 with a higher score indicating a better sense of smell, anosmia is defined as a score ≤7 |
| Recurrence rates | first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) | Increase of NPS per side ≥ 2 within 2 year follow-up |
| Sinonasal Symptom Score | first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) | nasal congestion, anterior rhinorrhea, posterior rhinorrhea, sneezing, pruritus in the nose, tearing, ear pressure, throat pain, facial pain or pressure, headache, numbness in cheek/lips/teeth. All graded from 0-3 (0=no problems, 1=mild problems, 2= moderate problems, 3= severe problems) |
| Lund-Kennedy-Score (LKS) | first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) | Lund-Kennedy-Scores range from 0-12. Scoring includes the assessment of polyps (0=no polyps, 1=middle meatus, 2= beyond middle meatus), discharge (0=no discharge, 1=thin discharge, 2=edema/scarring/crusting (0=absent, 1=mild, 2=severe) |
| RSDI (Rhinosinusitis Disability Index) | first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) | validated 30-item Likert scale instrument containing three subscales that assess the impact of sinusitis on physical, functional, and emotional domains. The Score ranges from 0-120. Higher total and subscale RSDI scores represent a worse impact of sinus disease. |
| SF-36 (Short Form-36) | first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) | There is no single overall score for the SF-36, instead, it generates 8 subscales and two summary scores. The subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role-limitations due to emotional problems, mental health. The scoring ranges from 0-100. Higher total and subscale scores represent a better health situation. |
| Mucus and serum biomarker levels | first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) | Pappalysin-1, Cystatin-SN, Periostin, SerpinE1, SerpinF2 (measured in pg/ml) |
Outcome results
None listed