ACTRN12618000693224已完成1 期
A single center, randomized, controlled, four way cross-over clinical study investigating the deposition of aerosol generated by the Nasal Mesh Nebulizer (NMN) prototype into the nasal cavity using radio-labelled saline at different pulse frequency in healthy volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 20 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Healthy Caucasian male
- •Aged >20 years
- •No history of smoking
- •No history of chronic lung diseases including asthma, cystic fibrosis, tuberculosis, chronic obstructive lung disease
- •Normal lung function with stable and reproducible baseline FEV1 of > 80% of predicted value following adjustment for height, age and gender according to the Global Lung Initiative equation.
- •No history of chronic sinusitis or rhinitis
- •Agree that CT scan data can be used post-study to generate an anatomically correct model of the upper respiratory tract
排除标准
- •Significant upper and lower respiratory infection within the previous 4 weeks
- •History of chronic sinusitis or rhinitis
- •History of recurrent lung infections.
- •History of chronic lung diseases
- •History of severe or multiple allergies, including hay-fever and perennial rhinitis
- •History of nasal fracture, nasal deformities or nasal polyps
- •History of disease, surgery, or abnormality of the upper respiratory tract, especially the nasal cavity.
- •History of significant nose bleeds
- •Participants using topical nasal medication e.g. decongestant, within the last 14 days of the first study day
- •Participants unable to perform pulmonary function test according to ATS/ERS criteria
- •Participants with documented or suspected, clinically significant alcohol or drug abuse
- •Current malignant or cardiovascular disease
- •Any serious or active medical or psychiatric illness
- •Current smokers, i.e. those who had smoked within the last 12 months and 6 hours prior to the scan. A negative Cotinine test must be demonstrated at each visit.
- •Participants who have any non-removable metal objects such as pacemakers, insulin/infusion pumps, cochlear and ear implant, metal plates, screws etc. in their head, neck, chest or abdominal area that may interfere with the /PET/SPECT/CT.
- •Nasal jewellery or nasal piercing
- •Participants with tattoos or permanent makeup above shoulder
- •Participants for whom participation in this study will exceed the limit of total radiation exposure allowed in any 12 months period (5 mSv), or will exceed 10 mSv over the last five-year period
研究者
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