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The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT03584178
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada

Brief Summary:
Chronic Rhinosinusitis (CRS) is a common disorder of the nose. The current practice at St Paul's Sinus Centre is to prescribe budesonide via the mucosal atomization device or impregnated saline irrigation. Both have shown to be a safe method of administration. A previous study demonstrated a 6% elevation in intraocular pressure and 3% prevalence of asymptomatic AdrenoCorticoTropic Hormone-Axis (ACTH) suppression. However, a baseline measurement was not conducted to ascertain the correlation of these findings with the medication. Therefore, the investigators aim to conduct baseline measurements of IntraOcular Pressure (IOP), ACTH-axis function, and Dual Energy X-ray Absorptiometry (DEXA) scan and obtaining regular measurements of these variables within a 12-month period to further ascertain these previous findings.

Condition or disease Intervention/treatment Phase
Sinusitis Device: Budesonide via MAD device Device: Budesonide via intranasals Saline Irrigation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Long-Term Safety of Budesonide Via Mucosal Atomization Device and Impregnated Nasal Saline Irrigations for Patients With Chronic Rhinosinusitis - A Prospective Double Cohort Study.
Estimated Study Start Date : July 25, 2018
Estimated Primary Completion Date : December 25, 2020
Estimated Study Completion Date : December 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Mucosal Atomization Device
Budesonide via MAD Device
Device: Budesonide via MAD device
Delivery through Mucosal Atomization Device
Other Name: Budesonide via Mucosal Atomization Device

Experimental: Intranasals Saline Irrigation
Budesonide via Intranasals Saline Irrigation
Device: Budesonide via intranasals Saline Irrigation
delivery via nasal irrigation bottle
Other Name: Intranasals Saline Irrigation




Primary Outcome Measures :
  1. Sinonasal-Outcomes Test-22 (SNOT-22) Questionnaire [ Time Frame: 1 year ]
    This sinus-specific questionnaire is divided into three parts consisting of 22 questions that are related to sinus health and health-related quality of life. This questionnaire was developed to assess symptoms and quality of life in patients suffering from CRS with or without nasal polyposis. Each question is scored on an ordinal, categorical scale ranging from 0 to 5. Patients are instructed to indicate if symptoms are "absent (0)", "very mild (1)", "mild (2)", "moderate (3)", "severe (4)" or "as bad as it can be (5)". The highest score achievable on this questionnaire is 110 points. Higher scores indicate greater symptom severity and burden on daily life. In a validation survey of 2803 subjects, the SNOT-22 showed high internal consistency, test-retest reliability and validity. The SNOT-22 was found to sufficiently distinguish between patients with CRS and healthy controls (P<0.0001, t=85.3).



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged between 19 years and above
  2. Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with nasal polyposis
  3. Patients with an upcoming Functional Endoscopic Sinus Surgery (FESS) procedure
  4. Patients being prescribed INCS for the first time following FESS

Exclusion Criteria:

  1. Individuals unable to understand the purpose, methods and conduct of this study
  2. Patients unwilling to provide informed consent
  3. Patients with significant comorbidities (such as tumour, CF, wegeners granulomatosis, immunocompromised)
  4. Patients with a history of pituitary disease
  5. Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin
  6. Patients with history of glaucoma or cataracts
  7. Recent use of systemic corticosteroids such as prednisone (within last 3 months)
  8. Patients that are not adherent to budesonide via MAD/INSI treatment

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): NCT03584178


Contacts
Contact: Amin Javer, MD 6048069926 sinusdoc@me.com
Contact: Sara Derikvand, PhD 6048069926 stpaulsinusresearch@gmail.com

Locations
Canada, British Columbia
St Paul Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
Principal Investigator: Amin Javer, MD University of British Columbia

Responsible Party: Amin Javer, Director, St. Paul's Sinus Centre, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT03584178     History of Changes
Other Study ID Numbers: H18-00458
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
ACTH-axis
Budesonide
MAD
INSI
Intraocular pressure
Bone density

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic 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