Sinusitis, ChronicPhase 4NCT04915456
Effect of Postoperative Additive Systemic Steroids in CRSwNP
A Phase 4 study testing Systemic Steroid (Prednisolone) in people with Sinusitis, Chronic, run by Friedrich-Alexander-Universität Erlangen-Nürnberg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis, Chronic
- What is being tested?
- Systemic Steroid (Prednisolone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2005to Feb 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CRSwNP
- refractory to medical therapy
- no previous sinus surgery
- Lund-Kennedy-Score ≥ 1
- Lund-Mackay-Score ≥ 10
Who cannot join
- ciliary impairment
- autoimmune disease
- cystic fibrosis
- immunodeficiency
About this study
Official title: Prospective Randomized, Placebo-controlled Clinical Study to Study the Effect of Postoperative Additive Systemic Steroids in Chronic Rhinosinusitis With Nasal Polyps
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.
- Conditions
- Sinusitis, Chronic
- Being tested
- Systemic Steroid (Prednisolone), Placebo
- Keywords
- steroid, recurrence, smell, biomarker, endoscopy
- Medical subject headings
- Sinusitis, Bronchiolitis Obliterans Syndrome, Recurrence, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic Steroid (Prednisolone)Drug
Systemic steroids (Prednisolone) additive to topical steroids (Mometasone fuorate) in a postoperative setting after FESS
PlaceboOther
Placebo additive to topical steroids in a postoperative setting after FESS
| Study group | Role | What they receive |
|---|---|---|
| Systemic steroid (Prednisolone) | Experimental | Prednisolone 50mg (tapered down until postoperative day (POD) 14, then 5mg for 14 days), tablets Receives: Drug: Systemic Steroid (Prednisolone) |
| Placebo | Placebo comparator | Lactose monohydrate, tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: 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
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
Measured: 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
Increase of NPS per side ≥ 2 within 2 year follow-up
Measured: 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
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)
Measured: 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
Pappalysin-1, Cystatin-SN, Periostin, SerpinE1, SerpinF2 (measured in pg/ml)
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start18 Jan 2005
- Primary completionApr 2020
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinusitis, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarina Mueller, Friedrich-Alexander-Universität Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915456
- Sponsor's protocol ID
- NP1
- Status last verified
- Jun 2021
- First submitted
- 24 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mueller SK, Wendler O, Mayr S, Traxdorf M, Koch M, Mantsopoulos K, Sievert M, Grundtner P, Iro H, Bleier BS. Comparison of mucus and serum biomarker sampling in chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2024 May;14(5):887-897. doi: 10.1002/alr.23295. Epub 2023 Nov 22.
PubMed 37990964
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized, Placebo-controlled Clinical Study to Study the Effect of Postoperative Additive Systemic Steroids in Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT04915456
- Acronym / sponsor ID
- NP1
- Conditions
- Sinusitis, Chronic
- Keywords
- steroid, recurrence, smell, biomarker, endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-NürnbergUniversity, hospital or other
- Study start
- 18 Jan 2005 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic steroid (Prednisolone) | Experimental | Drug: Systemic Steroid (Prednisolone)Prednisolone 50mg (tapered down until postoperative day (POD) 14, then 5mg for 14 days), tablets |
| Placebo | Placebo comparator | Other: PlaceboLactose monohydrate, tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CRSwNP
- refractory to medical therapy
- no previous sinus surgery
- Lund-Kennedy-Score ≥ 1
- Lund-Mackay-Score ≥ 10
Key exclusion criteria (4 listed)
- ciliary impairment
- autoimmune disease
- cystic fibrosis
- immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic Steroid (Prednisolone)Systemic steroids (Prednisolone) additive to topical steroids (Mometasone fuorate) in a postoperative setting after FESS | Drug | Systemic steroid (Prednisolone) |
| PlaceboPlacebo additive to topical steroids in a postoperative setting after FESS | Other | Placebo |
Primary outcome
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)
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Derived from this study: PubMed 37990964Mueller SK, Wendler O, Mayr S, Traxdorf M, Koch M, Mantsopoulos K, Sievert M, Grundtner P, Iro H, Bleier BS. Comparison of mucus and serum biomarker sampling in chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2024 May;14(5):887-897. doi: 10.1002/alr.23295. Epub 2023 Nov 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Systemic Steroid (Prednisolone) in people with Sinusitis, Chronic, run by Friedrich-Alexander-Universität Erlangen-Nürnberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.