Chronic RhinosinusitisNCT02748070

Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

A study testing Prednisone and Flonase in people with Chronic Rhinosinusitis and Endoscopic Sinus Surgery, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Chronic Rhinosinusitis Without Polyps
What is being tested?: Prednisone and Flonase
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 1 siteUnited States
Study dates: Aug 2015to 15 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
scheduled to undergo endoscopic sinus surgery

Who cannot join

chronic rhinosinusitis with polyps (CRSwNP)
Aspirin exacerbated respiratory disease
Cystic fibrosis
Immunosuppressive states (Human immunodeficiency virus, transplant)
Oral steroid use within 30 days of surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: The Role of Perioperative Systemic Steroids in Patients With Chronic Rhinosinusitis Without Polyps (CRSsNP)

While oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit in this disease state, steroids are often prescribed as a component of post-operative care after sinus surgery for patients without polyps. Oral steroids carry with them significant adverse effects, and should be prescribed thoughtfully. The aims of this study are to determine if oral steroids in the peri-operative period improves patient outcomes in CRS without polyps.

Conditions: Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Chronic Rhinosinusitis Without Polyps, Oral Steroids
Being tested: Prednisone, Flonase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrednisoneDrug
FlonaseDrug

Study groups in NCT02748070
Study group	Role	What they receive
Prednisone	Experimental	Provided oral steroid and topical steroid Receives: Drug: Prednisone; Drug: Flonase
Placebo	Placebo comparator	Provided oral placebo and topical steroid Receives: Drug: Flonase

What is being measured

The primary outcome is the main question the study is designed to answer.

Sino-nasal Outcome Test (SNOT-22) Over Time
SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
Measured: Baseline, 1, week, 1 month, 3 months, and 6 months
Lund Kennedy Endoscopy Score Over Time
The Lund-Kennedy score is a validated scale by which clinicians grade the endoscopic appearance of the sinonasal cavity for sinusitis patients. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. Higher scores represent a worse endoscopic appearance.
Measured: Baseline, 1, week, 1 month, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201515 Jul 2019

First posted22 Apr 2016 (estimated)
Study startAug 2015
Primary completion15 Jul 2019
Study completion15 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02748070
Sponsor's protocol ID: 33096
Status last verified: Jul 2020
First submitted: 15 Apr 2016
Last updated: 4 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Chang MT, Noel J, Ayoub NF, Qian ZJ, Dholakia S, Nayak JV, Patel ZM, Hwang PH. Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 May 1;147(5):434-441. doi: 10.1001/jamaoto.2021.0011.
PubMed 33662124

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease

All Chronic Rhinosinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Perioperative Systemic Steroids in Patients With Chronic Rhinosinusitis Without Polyps (CRSsNP)
ClinicalTrials.gov ID: NCT02748070
Acronym / sponsor ID: 33096
Conditions: Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Chronic Rhinosinusitis Without Polyps, Oral Steroids
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Aug 2015
Primary completion: 15 Jul 2019 (actual)
Study completion: 15 Jul 2019 (actual)
First posted: 22 Apr 2016 (estimated)
Results: Posted 24 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Prednisone	Experimental	Drug: Prednisone, Drug: FlonaseProvided oral steroid and topical steroid
Placebo	Placebo comparator	Drug: FlonaseProvided oral placebo and topical steroid

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
scheduled to undergo endoscopic sinus surgery

Key exclusion criteria (5 listed)

chronic rhinosinusitis with polyps (CRSwNP)
Aspirin exacerbated respiratory disease
Cystic fibrosis
Immunosuppressive states (Human immunodeficiency virus, transplant)
Oral steroid use within 30 days of surgery

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
Prednisone	Drug	Prednisone
Flonase	Drug	Placebo, Prednisone

Primary outcome

Sino-nasal Outcome Test (SNOT-22) Over Time
Time frame: Baseline, 1, week, 1 month, 3 months, and 6 months
SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
Lund Kennedy Endoscopy Score Over Time
Time frame: Baseline, 1, week, 1 month, 3 months, and 6 months
The Lund-Kennedy score is a validated scale by which clinicians grade the endoscopic appearance of the sinonasal cavity for sinusitis patients. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. Higher scores represent a worse endoscopic appearance.

Results and safety

Results posted to the registry on 24 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prednisone	41	33
Placebo	40	39

Primary outcome: Sino-nasal Outcome Test (SNOT-22) Over Time

Time frame: Baseline, 1, week, 1 month, 3 months, and 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Prednisone n = 33	Placebo n = 39
Baseline	43.8 (21.5)	42.9 (22.4)
1 week	39.7 (22.5)	38.5 (21.2)
1 month	26.6 (20.8)	28.6 (18.0)
3 months	28.3 (19.5)	20.3 (15.2)
6 months	34.2 (20.6)	25.2 (19.7)

Prednisone vs Placebo: p = 0.819, t-test, 2 sided
Prednisone vs Placebo: p = 0.665, t-test, 2 sided
Prednisone vs Placebo: p = 0.071, t-test, 2 sided

Population analysed: Participants who completed the protocol are included in the analysis.

Primary outcome: Lund Kennedy Endoscopy Score Over Time

Time frame: Baseline, 1, week, 1 month, 3 months, and 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Prednisone n = 33	Placebo n = 39
Baseline	2.9 (2.5)	3.8 (3.1)
1 week	5.9 (3.0)	5.3 (2.6)
1 month	3.5 (2.7)	3.8 (2.6)
3 months	1.9 (2.1)	2.4 (2.1)
6 months	1.3 (1.7)	1.8 (1.8)

Prednisone vs Placebo: p = 0.376, t-test, 2 sided
Prednisone vs Placebo: p = 0.685, t-test, 2 sided
Prednisone vs Placebo: p = 0.388, t-test, 2 sided

Population analysed: Participants who completed the protocol are included in the analysis.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prednisone	0 of 41 (0%)	14 of 41 (34.1%)	0 of 41
Placebo	0 of 40 (0%)	19 of 40 (47.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33662124Chang MT, Noel J, Ayoub NF, Qian ZJ, Dholakia S, Nayak JV, Patel ZM, Hwang PH. Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 May 1;147(5):434-441. doi: 10.1001/jamaoto.2021.0011.
Individual participant dataSharing planned: No

Related trials for Chronic Rhinosinusitis

RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease

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.

Julia E Noel, MD principal investigator

Stanford University

Michael T Chang, MD principal investigator

Stanford University

Peter H Hwang, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prednisone and Flonase in people with Chronic Rhinosinusitis and Endoscopic Sinus Surgery, run by Stanford University at 1 site in United States.

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 2 inclusion and 5 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 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sino-nasal Outcome Test (SNOT-22) Over Time (time frame: Baseline, 1, week, 1 month, 3 months, and 6 months). The study lists 2 primary outcomes in all. 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 NCT02748070, 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 4 Aug 2020.