NCT04915456

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2005

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

15.2 years

First QC Date

May 24, 2021

Last Update Submit

June 2, 2021

Conditions

Sinusitis, Chronic

Keywords

steroidrecurrencesmellbiomarkerendoscopy

Outcome Measures

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)

    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 (7)

  • 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)

  • 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)

  • 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)

  • +2 more secondary outcomes

Study Arms (2)

Systemic steroid (Prednisolone)

EXPERIMENTAL

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

Drug: Systemic Steroid (Prednisolone)

Placebo

PLACEBO COMPARATOR

Lactose monohydrate, tablets

Other: Placebo

Interventions

Systemic Steroid (Prednisolone)DRUG

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

Systemic steroid (Prednisolone)
PlaceboOTHER

Placebo additive to topical steroids in a postoperative setting after FESS

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CRSwNP
  • refractory to medical therapy
  • no previous sinus surgery
  • Lund-Kennedy-Score ≥ 1
  • Lund-Mackay-Score ≥ 10

You may not qualify if:

  • ciliary impairment
  • autoimmune disease
  • cystic fibrosis
  • immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SinusitisBronchiolitis Obliterans SyndromeRecurrenceAnosmia

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

May 24, 2021

First Posted

June 7, 2021

Study Start

January 18, 2005

Primary Completion

April 1, 2020

Study Completion

February 1, 2021

Last Updated

June 7, 2021

Record last verified: 2021-06