Skip to main content
OpenTrials
Completed

NCT Number: NCT04915456

Effect of Postoperative Additive Systemic Steroids in CRSwNP

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sinusitis, Chronic Anosmia Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Disease Attributes Graft vs Host Disease Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Neurologic Manifestations Nose Diseases Olfaction Disorders Organizing Pneumonia Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Signs and Symptoms Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systemic Steroid (Prednisolone)

Drug

Systemic steroids (Prednisolone) additive to topical steroids (Mometasone fuorate) in a postoperative setting after FESS

Placebo

Other

Placebo additive to topical steroids in a postoperative setting after FESS

Primary outcomes

  1. 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

  1. Lund-Kennedy-Score (LKS)

    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)

    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)

  2. Smell Scores

    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)

    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

  3. Recurrence rates

    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)

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

  4. Sinonasal Symptom Score

    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)

    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)

  5. Mucus and serum biomarker levels

    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)

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

  6. RSDI (Rhinosinusitis Disability Index)

    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)

    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.

  7. SF-36 (Short Form-36)

    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)

    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.

Sponsors and collaborators

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Other

Registry information

Official study title

Prospective Randomized, Placebo-controlled Clinical Study to Study the Effect of Postoperative Additive Systemic Steroids in Chronic Rhinosinusitis With Nasal Polyps

Important dates

Study start
2005
Primary completion
2020
Study completion
2021
First posted
Jun 7, 2021
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.