Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

NCT ID: NCT02119273

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-04-30

Brief Summary

Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited evidence to support their utility for CRSsNP. The investigators intend to perform a randomized, double blind, placebo controlled clinical trial to investigate the impact of steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present to the investigators office will be included if they have failed maximal medical management and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will improve subjective and objective outcome measures.

Conditions

Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Steroid

The steroid arm will take prednisone 10mg tabs starting 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days).

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

See arm description

Placebo

The placebo arm will receive placebo pills identical in appearance to prednisone 10mg pills. They will start taking them 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

See arm description

Interventions

Prednisone

See arm description

Intervention Type: DRUG

Placebo

See arm description

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients (ages 18-80) with a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) that have failed a 6 week trial of maximal medical therapy and have elected to undergo endoscopic sinus surgery will be offered enrollment in this study.
• Diagnosis of chronic rhinosinusitis (CRS) is based on the European Position on Rhinosinusitis (EPOS) 2012 guidelines.
• These include a greater than 12 week history of inflammation of the nose or paranasal sinuses characterized by at least 2 symptoms.
• These symptoms must include at least one of the following:

• nasal obstruction
• rhinorrhea
• postnasal drip.
• Additional symptoms can include facial pain/pressure or anosmia/hyposmia.
• These symptoms must be supplemented by either endoscopic signs of disease or characteristic CT changes.
• The presence or absence of nasal polyps defines the subtype (with polyps: CRSwNP; without polyps: CRSsNP).

Exclusion Criteria

• Patients will be excluded if they have nasal polyps or suspected allergic fungal rhinosinusitis (AFRS) based on classic endoscopy and CT findings.
• Additionally, patients with known immunocompromise or mucociliary disorders will be excluded.
• Patients that received oral corticosteroids within 6 weeks prior to the planned surgery will also be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Kristin Seiberling, MD

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Seiberling, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda Department of Otolaryngology

Locations

Loma Linda Sinus and Allergy Center

Redlands, California, United States

Countries

United States

Other Identifiers

5140031

Identifier Type: -

Identifier Source: org_study_id