Efficacy of Budesonide Via Delayed Release vs Immediate Release

NCT04476628 | Withdrawn Early Phase 1

• 1 other identifier: H20-00842
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the efficacy of intranasal budesonide administration with lying head back position and a 5 mins time to release of medication (5MR) compared to 1 min time to release (1MR) in chronic rhinosinusitis patients (CRS). Participants will be instructed to administer via mucosal automatization device (MAD) with either of the two treatment approaches daily for 5 to 7 days per week and 8 weeks total. This is a crossover study design so each participants will be placed in the other treatment approach for an additional 8 weeks of treatment. Moreover, there will be a "washout" of 2 weeks after baseline assessment and before the first treatment, as well as a second "washout" of 2 weeks between the two treatment approaches. The participants will also complete study related procedures such as endoscopic evaluation, cultures, and two questionnaires throughout the study period. The investigators hypothesize that Budesonide delivered to the sinuses with a 5 minute time to release of medication will be more effective at decreasing inflammation when compared to a 1 minute time to release of medication after administration.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Budesonide; MAD; CRS; Head Position; Timing of Release

Outcome Measures

Primary Outcomes (2)

• Change in Modified Lund Kennedy Score

  This score is based on the endoscopic assessment of polyps, edema, and discharge and are each given score 0-2. It is out of a total score of 12 with higher scores indicating a worse outcome.

  baseline and 20 weeks

• Change in Sinonasal-Outcomes Test-22 (SNOT-22) Score

  This is a standard of care baseline Sinonasal Outcome Test form that includes 22 questions about symptoms and social/emotional consequences of your nasal disorder. You will be asked to rate your problems as they have been over the past two weeks. An example of the questions is: * Need to blow nose * Sneezing It is out of a total of 110 and higher scores mean a worse outcome.

  baseline and 20 weeks

Secondary Outcomes (2)

• Change EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Score

  baseline and 20 weeks

• Change in sinus culture results

  baseline and 20 weeks

Study Arms (2)

Budesonide 5MR then 1MR

OTHER

All participants will administer budesonide daily via Mucosal Atomization Device (MAD) with a minimum requirement of at least five days a week for the duration of the study in this arm. 1. st time period: Patients will undergo a 2 week "washout" period. The "washout" period will involve standard of care daily non-medicated intranasal saline irrigation. 2. nd time period: 5MR administration method once daily for 8 weeks in duration. 3. rd time period: Patients will undergo a 2 week "washout" period of daily. The "washout" period will involve standard of care daily non-medicated intranasal saline irrigation. 4. th time period: 1MR administration method once daily for 8 weeks in duration.

Drug: Budesonide; Device: Mucosal Atomization Device; Device: NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation

Budesonide 1MR then 5MR

OTHER

All participants will administer budesonide daily via Mucosal Atomization Device (MAD) with a minimum requirement of at least five days a week for the duration of the study in this arm. 1. st time period: Patients will undergo a 2 week "washout" period. The "washout" period will involve standard of care daily non-medicated intranasal saline irrigation. 2. nd time period: 1MR administration method once daily for 8 weeks in duration. 3. rd time period: Patients will undergo a 2 week "washout" period of daily. The "washout" period will involve standard of care daily non-medicated intranasal saline irrigation. 4. th time period: 5MR administration method once daily for 8 weeks in duration.

Drug: Budesonide; Device: Mucosal Atomization Device; Device: NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation

Interventions

Budesonide DRUG

Budesonide is a corticosteroid that is commonly used intranasally to treat CRS.

Also known as: Pulmicort

Budesonide 1MR then 5MR; Budesonide 5MR then 1MR

Mucosal Atomization Device DEVICE

MAD is a device used as an addition to a syringe to atomize medication to increase area of distribution. It is used to administer budesonide within the nasal passages and sinuses to administer medication for CRS.

Budesonide 1MR then 5MR; Budesonide 5MR then 1MR

NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation DEVICE

INSI is delivered using a NeilMed squeeze bottle. It is used to administer budesonide within the nasal passages and sinuses to administer medication for CRS.

Also known as: INSI

Budesonide 1MR then 5MR; Budesonide 5MR then 1MR

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 19 years and above
• Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with or without nasal polyposis or allergic fungal rhinosinusitis.
• Patients currently on budesonide or being prescribed budesonide for the first time
• Minimum Modified Lund Kennedy score of 2.

You may not qualify if:

• Individuals unable to understand the purpose, methods and conduct of this study
• Patients unwilling to provide informed consent
• Are immuno-compromised, and have impairment in mucociliary function (e.g., cystic fibrosis, Kartagener syndrome)
• Have autoimmune diseases affecting the upper airway (eg Systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis etc)
• Have sinonasal tumors
• Patients with a history of pituitary disease
• Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin
• Recent use of systemic corticosteroids such as prednisone (within last 3 months)
• Patients who are pregnant or breastfeeding

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

MeSH Terms

Conditions

Disease

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Amin JAver, MD

  The University of British Columbia and St. Paul's Sinus Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: Patients will be randomly divided to either start with 5MR or 1MR administration methods. They will undergo a 2 week "washout" period before starting their respective administration method. The first administration methods will be once daily for 8 weeks in duration. This is then followed by an additional "washout" period of 2 weeks. Finally, patients will switch to the other administration method for an additional treatment duration of daily application for 8 weeks. We will assess which administration method is more effective. Patients will be asked to administer budesonide daily with a minimum requirement of at least five days a week to ensure changes seen are related to the appropriate treatment arm. The "washout" period will involve standard of care daily non-medicated intranasal saline irrigation. Data will be collected at baseline, 2 weeks, 10 weeks, 12 weeks, and lastly 20 weeks follow-up visit.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 20, 2020
• Study Start: February 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 28, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share