Prospective Double-Cohort Study: Comparing Efficacy of Budesonide Via Delayed Release vs Immediate Release After Administration in the Lying Head Back Position
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change in Modified Lund Kennedy Score
研究概览
简要总结
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.
详细描述
Objective
To compare the efficacy of 1 minute versus 5 minutes time to release of budesonide with lying head back position following administration via mucosal atomization device (MAD).
Hypothesis
Budesonide delivered to the sinuses with lying head back position and a 5 minute time to release (5MR) of medication will be more effective at decreasing inflammation both objectively and subjectively when compared to 1 minute time to release (1MR) of medication after administration.
Baseline and Follow-up Visits Evaluation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Budesonide 5MR then 1MR
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.
- 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.
- nd time period: 5MR administration method once daily for 8 weeks in duration.
- 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.
- th time period: 1MR administration method once daily for 8 weeks in duration.
干预措施: Budesonide (Drug)
Budesonide 5MR then 1MR
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.
- 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.
- nd time period: 5MR administration method once daily for 8 weeks in duration.
- 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.
- th time period: 1MR administration method once daily for 8 weeks in duration.
干预措施: Mucosal Atomization Device (Device)
Budesonide 5MR then 1MR
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.
- 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.
- nd time period: 5MR administration method once daily for 8 weeks in duration.
- 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.
- th time period: 1MR administration method once daily for 8 weeks in duration.
干预措施: NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation (Device)
Budesonide 1MR then 5MR
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.
- 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.
- nd time period: 1MR administration method once daily for 8 weeks in duration.
- 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.
- th time period: 5MR administration method once daily for 8 weeks in duration.
干预措施: Budesonide (Drug)
Budesonide 1MR then 5MR
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.
- 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.
- nd time period: 1MR administration method once daily for 8 weeks in duration.
- 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.
- th time period: 5MR administration method once daily for 8 weeks in duration.
干预措施: Mucosal Atomization Device (Device)
Budesonide 1MR then 5MR
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.
- 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.
- nd time period: 1MR administration method once daily for 8 weeks in duration.
- 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.
- th time period: 5MR administration method once daily for 8 weeks in duration.
干预措施: NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation (Device)
结局指标
主要结局
Change in Modified Lund Kennedy Score
时间窗: baseline and 20 weeks
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.
Change in Sinonasal-Outcomes Test-22 (SNOT-22) Score
时间窗: baseline and 20 weeks
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.
次要结局
- Change in sinus culture results(baseline and 20 weeks)
- Change EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Score(baseline and 20 weeks)
研究者
Amin Javer
Assistant Clinical Professor
St. Paul's Hospital, Canada