Effect of Postoperative Additive Systemic Steroids in CRSwNP

Browse trials for

• Sinusitis 415

Keywords

• steroid
• recurrence
• smell
• biomarker
• endoscopy

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's enrollment of 106 is above the median of 60 across 313 interventional studies indexed under Sinusitis.

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Study arms

• Experimental
  Systemic steroid (Prednisolone)

  Prednisolone 50mg (tapered down until postoperative day (POD) 14, then 5mg for 14 days), tablets

  Drug: Systemic Steroid (Prednisolone)

• Placebo comparator
  Placebo

  Lactose monohydrate, tablets

  Other: Placebo

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

Primary outcomes

1. Nasal Polyp Score (NPS)

   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)

   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)

Secondary outcomes

1. Lund-Kennedy-Score (LKS)

   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)

   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)

2. Smell Scores

   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

   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)

3. Recurrence rates

   Increase of NPS per side ≥ 2 within 2 year follow-up

   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)

4. Sinonasal Symptom Score

   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)

   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)

5. Mucus and serum biomarker levels

   Pappalysin-1, Cystatin-SN, Periostin, SerpinE1, SerpinF2 (measured in pg/ml)

   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)

6. RSDI (Rhinosinusitis Disability Index)

   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.

   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)

7. SF-36 (Short Form-36)

   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.

   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)