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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02696850
First received: February 26, 2016
Last updated: April 26, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Rhinosinusitis Chronic Eosinophilic Rhinosinusitis Allergic Rhinosinusitis Drug: Budesonide Drug: Saline alone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Jay F. Piccirillo, MD, Washington University School of Medicine:

Primary Outcome Measures:
  • Change in SNOT-22 (Sino-Nasal Outcome Test) [ Time Frame: baseline/ 2 weeks /4 weeks ]

    Study participants will be asked to complete the SNOT-22 at baseline, two weeks, and four weeks. The SNOT-22 score will be calculated as the average per item score for each of the 22 items and the value will range between 0 and 5. For subjects who answer less than 22 items (i.e., don't completely answer the SNOT-22), the total score will be the average per item value for the items that were answered. The change in 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-22baseline — SNOT-224-week follow-up. To assess the trajectory of change within subjects randomized to the two treatment arms the baseline, two-week, and four-week SNOT-22 assessment will be compared.



Secondary Outcome Measures:
  • Change in CGI scale (Clinical Global Impression) [ Time Frame: week 4 ]
    The overall response to treatment will be measured with a modification of the Clinical Global Impression (CGI) scale. Upon completion of the study, subjects will be asked to answer the following question: "Overall, how would you rate your response to treatment?" Response options are: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse.


Other Outcome Measures:
  • Physical examination [ Time Frame: baseline/ week 4 ]
    A directed physical examination, consisting of examination of the nasal cavity with a 0-degree rigid nasal endoscope, will be performed by a board-certified otolaryngologist after application of topical decongestant at baseline and after completion of the four week intervention. The findings from the endoscopic examination will be collected for research purposes and will be recorded using the grading system proposed by Lund and Kennedy.(Lund and Kennedy 1997) The assessment will be made on a 3-point Likert scale.

  • Radiologic examination [ Time Frame: baseline/ week 1 / week 2 / week 3 / week 4 ]
    Radiologic examination, including CT scan of the sinuses, will not be required for enrollment in the study. Enrolled subjects who receive a CT scan of the sinuses for clinical reasons during the period of this study will have the results of the radiologic examination collected for research purposes and will be recorded according to the Lund MacKay system and possibly included in the data analysis.CT evidence of inflammation of the sinuses will be defined as mucosal thickening of at least one paranasal sinus and does not have to be severe enough to be classified as "partial opacification" or have a Lund and MacKay score of 1 or greater.


Enrollment: 80
Actual Study Start Date: January 1, 2016
Study Completion Date: April 13, 2017
Primary Completion Date: April 13, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide

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
Participants will undergo 4-week treatment course that includes budesonide powder added to saline rinse.
Placebo Comparator: Saline Alone
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
Participants will undergo 4-week treatment course that includes lactose (placebo) powder added to saline rinse.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02696850

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine
  More Information

Publications:

Study Data/Documents: Questionnaire  This link exits the ClinicalTrials.gov site
Identifier: CGI scale

Responsible Party: Jay F. Piccirillo, MD, Professor, Otolaryngology - Head and Neck Surgery Director, Clinical Outcomes Research Office, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02696850     History of Changes
Other Study ID Numbers: 201512063
Study First Received: February 26, 2016
Last Updated: April 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Jay F. Piccirillo, MD, Washington University School of Medicine:
sinusitis
rhinosinusitis
rhinitis
nasal lavage

Additional relevant MeSH terms:
Sinusitis
Rhinitis, Allergic
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Rhinitis
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 21, 2017