The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

NCT02696850 | Completed Phase 4 Results DMC

• 1 other identifier: 201512063
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research project is to explore the impact of the addition of budesonide to high-volume, low-pressure nasal sinus saline irrigation (aka "Neti-Pot"-type systems) for patients with chronic rhinosinusitis with or without nasal polyps.

Conditions

Rhinosinusitis; Chronic Eosinophilic Rhinosinusitis; Allergic Rhinosinusitis

Keywords

sinusitis; rhinosinusitis; rhinitis; nasal lavage

Outcome Measures

Primary Outcomes (1)

• Change in SNOT-22 (Sino-Nasal Outcome Test)

  The change in Sino-Nasal Outcome test (SNOT-22) scores between baseline and four weeks will serve as the primary outcome measure in this study and will be calculated as: Primary Outcome Measure, ∆SNOT-22 = SNOT-22 baseline - SNOT-22 4-week follow-up. The change in SNOT-22 score is measured on a scale from -110 to 110 with positive scores showing improvement with treatment and negative scores showing worse condition after treatment.

  Baseline to 4 weeks

Secondary Outcomes (1)

• Clinical Global Impression of Change (CGI)

  4 weeks

Other Outcomes (1)

• Change in Endoscopic Scores

  Baseline to 4 weeks

Study Arms (2)

Budesonide

EXPERIMENTAL

The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily. Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.

Drug: Budesonide

Saline Alone

PLACEBO COMPARATOR

Each study bottle will contain 60 capsules of placebo, which is lactose monohydrate and will be supplied in clear plastic capsules identical to the budesonide capsules. Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily.

Drug: Saline alone

Interventions

Budesonide DRUG

Participants will undergo 4-week treatment course that includes budesonide powder added to saline rinse.

Budesonide

Saline alone DRUG

Participants will undergo 4-week treatment course that includes lactose (placebo) powder added to saline rinse.

Saline Alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS)
• mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion),facial pain-pressure-fullness, and decreased sense of smell
• AND inflammation documented by one or more of the following findings:
• purulent (not clear) mucus or edema in the middle meatus or ethmoid region,
• polyps in nasal cavity or the middle meatus, and/or
• radiographic imaging showing inflammation of the paranasal sinuses

You may not qualify if:

• Unable to speak English
• History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition
• Dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease.
• History of oral or systematic antibiotic use in the past 2 weeks
• History of nasal or sinus surgery within past 6 weeks
• History of cerebrospinal fluid leak
• History of allergy to budesonide or other topical steroids
• Pregnant or breast feeding
• Current infection or history of one of the following infections: Tuberculosis (TB) lung infection, or Herpes infection of the eye.
• Baseline SNOT-22 total scores below 9 were excluded due to the inability to achieve a minimally clinically improved difference

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (8)

• Report of the Rhinosinusitis Task Force Committee Meeting. Alexandria, Virginia, August 17, 1996. Otolaryngol Head Neck Surg. 1997 Sep;117(3 Pt 2):S1-68. No abstract available.

  PMID: 9380416 BACKGROUND

• Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs M, Kennedy DW, Lanza DC, Marple BF, Osguthorpe JD, Stankiewicz JA, Anon J, Denneny J, Emanuel I, Levine H. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg. 2003 Sep;129(3 Suppl):S1-32. doi: 10.1016/s0194-5998(03)01397-4. No abstract available.

  PMID: 12958561 BACKGROUND

• Snidvongs K, Pratt E, Chin D, Sacks R, Earls P, Harvey RJ. Corticosteroid nasal irrigations after endoscopic sinus surgery in the management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2012 Sep-Oct;2(5):415-21. doi: 10.1002/alr.21047. Epub 2012 May 7.

  PMID: 22566474 BACKGROUND

• Sachanandani NS, Piccirillo JF, Kramper MA, Thawley SE, Vlahiotis A. The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):303-7. doi: 10.1001/archoto.2008.555.

  PMID: 19289711 BACKGROUND

• Steinke JW, Payne SC, Tessier ME, Borish LO, Han JK, Borish LC. Pilot study of budesonide inhalant suspension irrigations for chronic eosinophilic sinusitis. J Allergy Clin Immunol. 2009 Dec;124(6):1352-4.e7. doi: 10.1016/j.jaci.2009.09.018. No abstract available.

  PMID: 19910027 BACKGROUND

• Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002 Jan;126(1):41-7. doi: 10.1067/mhn.2002.121022.

  PMID: 11821764 BACKGROUND

• Browne JP, Hopkins C, Slack R, Cano SJ. The Sino-Nasal Outcome Test (SNOT): can we make it more clinically meaningful? Otolaryngol Head Neck Surg. 2007 May;136(5):736-41. doi: 10.1016/j.otohns.2007.01.024.

  PMID: 17478207 BACKGROUND

• Tait S, Kallogjeri D, Suko J, Kukuljan S, Schneider J, Piccirillo JF. Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):605-612. doi: 10.1001/jamaoto.2018.0667.

  PMID: 29879268 DERIVED

MeSH Terms

Conditions

Rhinosinusitis; Rhinitis, Allergic, Perennial; Sinusitis; Rhinitis

Interventions

Budesonide; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Rhinitis, Allergic; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The duration of the trial was only four weeks may have been an insufficient amount of time to see the complete effect of the budesonide therapy for chronic rhino-sinusitis. Compliance was assessed with patient self-reports.

Results Point of Contact

• Title: Dr. Jay F. Piccirillo, Principal Investigator
• Organization: WashingtonU

piccirij@wustl.edu

(314) 362-8641

Study Officials

• Jay F Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 2, 2016
• Study Start: January 1, 2016
• Primary Completion: April 13, 2017
• Study Completion: April 13, 2017
• Last Updated: September 3, 2019
• Results First Posted: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)