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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696850
Recruitment Status : Completed
First Posted : March 2, 2016
Results First Posted : September 3, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Rhinosinusitis Chronic Eosinophilic Rhinosinusitis Allergic Rhinosinusitis Drug: Budesonide Drug: Saline alone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : April 13, 2017
Actual Study Completion Date : April 13, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in SNOT-22 (Sino-Nasal Outcome Test) [ Time Frame: Baseline to 4 weeks ]

    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.



Secondary Outcome Measures :
  1. Clinical Global Impression of Change (CGI) [ Time Frame: 4 weeks ]
    The overall response to treatment will be measured with a modification of the Clinical Global Impression of change (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. Higher scores mean worse response to treatment.


Other Outcome Measures:
  1. Change in Endoscopic Scores [ Time Frame: Baseline to 4 weeks ]
    The change in Endoscopic Scores will be defined as the difference in the Lund-Kennedy Endoscopic score at baseline minus the Lund-Kennedy Endoscopic Score at 4 weeks and will be measured as the difference in scores on a scale that ranges from 0 to 20. Larger positive change reflects better response to treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696850


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:

Study Data/Documents: Questionnaire  This link exits the ClinicalTrials.gov site
Identifier: SNOT-22
Questionnaire  This link exits the ClinicalTrials.gov site
Identifier: CGI scale

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02696850    
Other Study ID Numbers: 201512063
First Posted: March 2, 2016    Key Record Dates
Results First Posted: September 3, 2019
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Washington University School of Medicine:
sinusitis
rhinosinusitis
rhinitis
nasal lavage
Additional relevant MeSH terms:
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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