SinusitisNCT03584178
The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis
A study testing Budesonide via MAD device and Budesonide via intranasals Saline Irrigation in people with Sinusitis, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- Budesonide via MAD device and Budesonide via intranasals Saline Irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 5 Sep 2018to 25 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 19 years and above
- Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with nasal polyposis
- Patients with an upcoming Functional Endoscopic Sinus Surgery (FESS) procedure
- Patients being prescribed INCS for the first time following FESS
Who cannot join
- Individuals unable to understand the purpose, methods and conduct of this study
- Patients unwilling to provide informed consent
- Patients with significant comorbidities (such as tumour, CF, wegeners granulomatosis, immunocompromised)
- Patients with a history of pituitary disease
- Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin
- Patients with history of glaucoma or cataracts
- Recent use of systemic corticosteroids such as prednisone (within last 3 months)
- Patients that are not adherent to budesonide via MAD/INSI treatment
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Paul Hospital
Vancouver, British Columbia, V6Z 1Y6
Sara Derikvand, PhD, 6048069926, stpaulsinusresearch@gmail.com
Amin Javer, MD, 6048069926, sinusdoc@me.com
About this study
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.
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.
Read the detailed description
Purpose:
The purpose of this study is to assess the long-term effects of budesonide via MAD (Mucosal Atomization Device) or INSI (Intranasal Saline Irrigation) on intraocular pressure, ACTH-axis function, and bone-density.
Hypothesis:
Budesonide delivered via MAD or INSI will be safe in the long-term (> 12 months) demonstrated objectively via IOP, ACTH stimulation test, and DEXA scan.
Justification:
The safety profile of both MAD and INSI has been widely studied in the literature. Although both modalities are generally considered safe, several studies have demonstrated asymptomatic hypothalamic-pituitary-adrenal axis (HPAA) suppression when used in the long-term. A cross-sectional study at St Paul's Sinus Centre, found 3% of study participants on long-term maintenance treatment via MAD to have asymptomatic HPAA suppression. However, the cross-sectional study design limited the ability to ascertain the timeline for this adverse event.
Although the recent cross-sectional study at St Paul Sinus Centre was the first to study the long-term effects of budesonide via the MAD in CRS patients, it did not include baseline levels of HPAA function and IOP levels which served as a limitation to ascertaining the timeline of the aforementioned adverse events. Additionally, there is currently limited data on the effects of INCS on bone function in the setting of CRS treatment. Therefore, this study aims to prospectively assess the long-term effect of high-dose nasal corticosteroids (i.e. INSI and MAD) in CRS patients. The study design will obtain baseline measurements of ACTH function, IOP measurement, and a DEXA scan to identify and describe the timeline of adverse events should they develop during the 12-month study period. By determining the impact of nasal corticosteroids on these outcomes, potential improvements can be made in the safety monitoring practices of otolaryngologists. This may include more frequent monitoring of intraocular pressure, Bone Mineral Density (BMD), and HPAA-axis function in at-risk populations, development of budesonide tapering guidelines, and improved screening of patient-reported adverse events. Overall, the investigators hope the results from this study will be a step forward in the development of screening guidelines for monitoring patients on long-term IntraNasal CorticoSteroids (INCS) therapy.
Primary Objective:
To assess long-term safety (> 12 months) of budesonide delivered via MAD or INSI as measured objectively via IOP, ACTH stimulation test, and DEXA scan.
Research Design:
A Prospective Double-Cohort Study
Statistical Analysis:
Descriptive statistics will be used to analyze the baseline characteristic data and the data from the administered surveys and objective findings of ACTH stimulation test, IOP measurement, and DEXA scans. In addition, rigorous statistical analysis will be conducted on the Likert scale-based SinoNasal Outcome Test (SNOT-22) and EuroQuol health-related quality of life surveys (EQ-5D-5L). These analyses will include cross-tabulations (Pearson's chi square test) and confidence interval calculations. Due to the variations in baseline intraocular pressure measurements, the investigators will calculate an adjusted difference instead of absolute values.
- Conditions
- Sinusitis
- Being tested
- Budesonide via MAD device, Budesonide via intranasals Saline Irrigation
- Keywords
- ACTH-axis, Budesonide, MAD, INSI, Intraocular pressure, Bone density
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide via MAD deviceDevice
Also called Budesonide via Mucosal Atomization Device
Delivery through Mucosal Atomization Device
Budesonide via intranasals Saline IrrigationDevice
Also called Intranasals Saline Irrigation
delivery via nasal irrigation bottle
| Study group | Role | What they receive |
|---|---|---|
| Mucosal Atomization Device | Experimental | Budesonide via MAD Device Receives: Device: Budesonide via MAD device |
| Intranasals Saline Irrigation | Experimental | Budesonide via Intranasals Saline Irrigation Receives: Device: Budesonide via intranasals Saline Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinonasal-Outcomes Test-22 (SNOT-22) Questionnaire
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start5 Sep 2018
- Primary completion25 Dec 2020 (estimated)
- Study completion25 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Javer, St. Paul's Hospital, Canada
- Investigators
- Amin Javer, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584178
- Sponsor's protocol ID
- H18-00458
- Status last verified
- Sep 2019
- First submitted
- 18 Jun 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03584178
- Acronym / sponsor ID
- H18-00458
- Conditions
- Sinusitis
- Keywords
- ACTH-axis, Budesonide, MAD, INSI, Intraocular pressure, Bone density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 25 Dec 2020 (estimated)
- Study completion
- 25 Dec 2021 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose:
The purpose of this study is to assess the long-term effects of budesonide via MAD (Mucosal Atomization Device) or INSI (Intranasal Saline Irrigation) on intraocular pressure, ACTH-axis function, and bone-density.
Hypothesis:
Budesonide delivered via MAD or INSI will be safe in the long-term (> 12 months) demonstrated objectively via IOP, ACTH stimulation test, and DEXA scan.
Justification:
The safety profile of both MAD and INSI has been widely studied in the literature. Although both modalities are generally considered safe, several studies have demonstrated asymptomatic hypothalamic-pituitary-adrenal axis (HPAA) suppression when used in the long-term. A cross-sectional study at St Paul's Sinus Centre, found 3% of study participants on long-term maintenance treatment via MAD to have asymptomatic HPAA suppression. However, the cross-sectional study design limited the ability to ascertain the timeline for this adverse event.
Although the recent cross-sectional study at St Paul Sinus Centre was the first to study the long-term effects of budesonide via the MAD in CRS patients, it did not include baseline levels of HPAA function and IOP levels which served as a limitation to ascertaining the timeline of the aforementioned adverse events. Additionally, there is currently limited data on the effects of INCS on bone function in the setting of CRS treatment. Therefore, this study aims to prospectively assess the long-term effect of high-dose nasal corticosteroids (i.e. INSI and MAD) in CRS patients. The study design will obtain baseline measurements of ACTH function, IOP measurement, and a DEXA scan to identify and describe the timeline of adverse events should they develop during the 12-month study period. By determining the impact of nasal corticosteroids on these outcomes, potential improvements can be made in the safety monitoring practices of otolaryngologists. This may include more frequent monitoring of intraocular pressure, Bone Mineral Density (BMD), and HPAA-axis function in at-risk populations, development of budesonide tapering guidelines, and improved screening of patient-reported adverse events. Overall, the investigators hope the results from this study will be a step forward in the development of screening guidelines for monitoring patients on long-term IntraNasal CorticoSteroids (INCS) therapy.
Primary Objective:
To assess long-term safety (> 12 months) of budesonide delivered via MAD or INSI as measured objectively via IOP, ACTH stimulation test, and DEXA scan.
Research Design:
A Prospective Double-Cohort Study
Statistical Analysis:
Descriptive statistics will be used to analyze the baseline characteristic data and the data from the administered surveys and objective findings of ACTH stimulation test, IOP measurement, and DEXA scans. In addition, rigorous statistical analysis will be conducted on the Likert scale-based SinoNasal Outcome Test (SNOT-22) and EuroQuol health-related quality of life surveys (EQ-5D-5L). These analyses will include cross-tabulations (Pearson's chi square test) and confidence interval calculations. Due to the variations in baseline intraocular pressure measurements, the investigators will calculate an adjusted difference instead of absolute values.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucosal Atomization Device | Experimental | Device: Budesonide via MAD deviceBudesonide via MAD Device |
| Intranasals Saline Irrigation | Experimental | Device: Budesonide via intranasals Saline IrrigationBudesonide via Intranasals Saline Irrigation |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 19 years and above
- Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with nasal polyposis
- Patients with an upcoming Functional Endoscopic Sinus Surgery (FESS) procedure
- Patients being prescribed INCS for the first time following FESS
Key exclusion criteria (8 listed)
- Individuals unable to understand the purpose, methods and conduct of this study
- Patients unwilling to provide informed consent
- Patients with significant comorbidities (such as tumour, CF, wegeners granulomatosis, immunocompromised)
- Patients with a history of pituitary disease
- Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide via MAD deviceAlso: Budesonide via Mucosal Atomization DeviceDelivery through Mucosal Atomization Device | Device | Mucosal Atomization Device |
| Budesonide via intranasals Saline IrrigationAlso: Intranasals Saline Irrigationdelivery via nasal irrigation bottle | Device | Intranasals Saline Irrigation |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Sinusitis
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amin Javer, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide via MAD device and Budesonide via intranasals Saline Irrigation in people with Sinusitis, run by St. Paul's Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amin Javer, MD (6048069926, sinusdoc@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinonasal-Outcomes Test-22 (SNOT-22) Questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.