Open Label Two -Treatment Half Side Comparative Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasoen Propionate
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- bioavailability of MP29-02 in human nasal mucosa compared to commercially available fluticasone propionate
研究概览
简要总结
The aim of this study is to investigate and to compare the bioavailability of MP29-02 and fluticasone propionate in nasal tissue after nasal application. This may provide a rational basis for the use of 1 puff per nostril dosage regimen of the drugs. Clinical experience has demonstrated the efficacy of the twice-daily treatment; however, so far, no data are available on the local tissue concentrations of MP29-02 after topical application.
详细描述
The study will be a single-centre, two-treatment half-side comparative open-label trial; all subjects will receive Dymista® or Flixonase Aqua in one nostril each.
Nasal tissue samples will be obtained from 24 patients. Subjects will be selected based on the subjects plan to undergo septoplasty, septorhinoplasty, or functional endoscopic sinus surgery. Subjects with different diagnoses can be added in the study: non-allergic rhinitis, allergic rhinits, chronic sinusitis and nasal polyposis. The number of subjects is based on a previous experiment where the presence of fluticasone propionate was tested on human nasal mucosal surface and in human nasal tissue after nasal application (Bonsmann, 2001).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Male and female patients
- •Age: 18 - 70 years (included)
- •Subjects who need to undergo septoplasty, septorhinoplasty or functional endoscopic sinus surgery unrelated to this study
- •Willing and able to provide informed consent
排除标准
- •- Patients who are member of the staff or relatives thereof directly involved in the conduct of the protocol
- •Participant in any other trial during the last 30 days
- •Previous treatment with Dymista or any other topical corticosteroid spray or drops within the last month before the operation
- •Previous treatment with systemic corticosteroid in the last 2 months before operation
- •Previous treatment with anti-histaminics 7 days before operation
- •Pregnant or breast feeding women
- •Allergic for one of the compounds azelastinehydrochloride or fluticasonpropionate
- •Significant co-morbidity (for instance, but not limited to):
- •Glaucoma, cataracts, and increased intraocular pressure.
- •Subjects with active or quiescent tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex
- •Subjects with severe liver disease
- •Use of prohibited concomitant medication
- •Potent inhibitors of cytochrome P450 (CYP) 3A4
- •Ritonavir
- •Patients unwilling or unable to attend the proposed visit schedule
- •Patients suspected or known not to be trustworthy or who are likely not to comply with the study directives
研究组 & 干预措施
Investigational product
MP29-02 137
干预措施: MP29-02 (Drug)
Non-investigational product
fluticasone propionate
干预措施: Fluticasone propionate (Drug)
结局指标
主要结局
bioavailability of MP29-02 in human nasal mucosa compared to commercially available fluticasone propionate
时间窗: 1 hour
bioavailability of both medicines will be tested in nasal mucosa and nasal secretion 1 after application
次要结局
未报告次要终点