Prospective Randomized, Placebo-controlled Clinical Study to Study the Effect of Postoperative Additive Systemic Steroids in Chronic Rhinosinusitis With Nasal Polyps
Overview
- Phase
- Phase 4
- Intervention
- Systemic Steroid (Prednisolone)
- Conditions
- Sinusitis, Chronic
- Sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Enrollment
- 106
- Primary Endpoint
- Nasal Polyp Score (NPS)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Sarina Mueller
PD Dr. med.
Friedrich-Alexander-Universität Erlangen-Nürnberg
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Systemic steroid (Prednisolone)
Prednisolone 50mg (tapered down until postoperative day (POD) 14, then 5mg for 14 days), tablets
Intervention: Systemic Steroid (Prednisolone)
Placebo
Lactose monohydrate, tablets
Intervention: Placebo
Outcomes
Primary Outcomes
Nasal Polyp Score (NPS)
Time Frame: 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 Outcomes
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))