ACTRN12624000772549尚未招募1 期
A pilot study to evaluate the effectiveness of intranasal Botulinum Toxin Type A Spray for adult patients with Rhinitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1. Patients greater than or equal to 18 years
- •2. Clinically confirmed diagnosis of allergic or non-allergic rhinitis.
- •3. Prior Radioallergosorbent test (RAST) test and immunoglobulin E ( IgE) level (as part of the patient’s standardised medical treatment).
- •4. Incomplete management of symptoms despite appropriate medical treatment (intra-nasal corticosteroid and nasal douching)
排除标准
- •1. Patients less than 18 years
- •2. Participants who are unable to provide informed consent.
- •3. Participants who are pregnant, breast feeding or planning to become pregnant during study.
- •4. Participants with an absolute contraindication to botulinum toxin type A specifically allergy, pregnancy, coexisting myasthenia gravis.
- •5. Coexisting chronic rhinosinusitis.
- •6. Subjects with known hypersensitivity or contraindications to mometasone nasal spray.
- •7. Participants who have been on an active investigational therapy within 1 month prior to screening
- •8. Women of childbearing potential who are not willing to use double barrier method of contraception during the study. That is:
- •-Use of contraceptive pill or intrauterine device (IUD) or similar
- •-and Condoms
- •9. Currently on any medication that may affect the results in an unpredictable manner.
- •10. The participant does not agree to comply with or is unable to meet all study requirements for the duration of the study period.
- •11. Participants deemed by the investigator to be unsuitable for participation in the study.
研究者
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