EUCTR2005-001297-27-GB进行中（未招募）1 期
Comparative Efficacy & Safety of Two Intranasal Fluticasone Propionate Formulations in Persistent Allergic Rhinitis - N/A
eolab td0 个研究点目标入组 22 人开始时间: 2005年4月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Written informed consent.
- •2. Male or female between 18 and 70 years of age inclusive.
- •3. Diagnosis of persistent allergic rhinitis.
- •4. Skin-prick positive to at least one common aeroallergen.
- •5. Score on miniRQLQ of =1 following a 2 week run-in period.
- •6. Willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD) (women of childbearing potential only).
- •7. In the opinion of the investigator, able to comply with the requirements of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known or suspected hypersensitivity to fluticasone propionate or any other constituents of the Investigational Medicinal product (IMP).
- •2. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
- •3. Nasal polyposis (Grade 2+) or significant (=50%) septal deviation.
- •4. Asthmatic patients receiving doses of inhaled corticosteroids greater than 800µg beclometasone dipropionate or equivalent unless their dose has been stable for at least 28 days
- •5. Females who are pregnant, lactating or planning to become pregnant.
- •6. Clinically significant laboratory test results, as judged by the investigator.
- •7. Patients with seasonal allergic rhinitis classified as severe according to the ARIA Guidelines, in addition to a positive skin prick test to grass pollen.
- •8. Patients previously enrolled into this study, except those screened and excluded on the grounds of inclusion criteria number 5 prior to amendment 4 (protocol v2), and those that declined randomisation due to visit timing difficulties prior to the same amendment.
- •9. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening, except where related to previous screening (i.e. placebo run-in) for this study prior to amendment 4 (protocol v2).
- •10. Patients who are scheduled to receive any other investigational drug during the course of the study.
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