EUCTR2014-004564-38-DE进行中（未招募）1 期
A randomised, open label, two-period, cross-over, multi-centre study to compare correct inhaler handling of fluticasone/ formoterol breath-actuated inhaler (K-haler®) with that of Symbicort® Turbohaler® in subjects with persistent asthma, ACOS or COPD. - Preference and Ease of use of Fluticasone/FormotERol K-haler (Preffer) study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 368
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
- 性别
- All
入选标准
- •1. Written informed consent/assent.
- •2. Male and female subject’s =18 years old.
- •3. Female subjects less than one year post-menopausal must have a negative urine pregnancy test prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), true sexual abstinence, where this is in line with the preferred and usual lifestyle of the subject, or vasectomized partner. Note: Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for duration of study, and withdrawal are not acceptable methods of contraception).
- •4. Documented history of asthma, ACOS or COPD for = 6 months prior to Visit 1.
- •5. Subjects currently using Seretide® Accuhaler®/ Viani® Diskus® (100/50 bid, 250/50 bid or 500/50 bid) for at least 3 months prior to Visit 1 and naïve to Turbohaler® (whether containing SABA, ICS or ICS-LABA) and K-haler.
- •6. Subject currently uses a specific reliever(s) device(s) for at least 3 months prior to Visit 1.
- •7. Can perform spirometry adequately.
- •8. Willing and able to attend all study visits.
- •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 221
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 147
排除标准
- •1. Any severe chronic respiratory disease other than asthma, ACOS or COPD.
- •2. Subjects that have previously used Turbohaler® (whether containing SABA, ICS or ICS-LABA) and/or the K-haler®.
- •3. Subjects currently using Seretide® Accuhaler®/Viani® Diskus® 500/50 bid in whom the Investigator considers it a risk to patient safety to switch to Symbicort® 400/12 bid or fluticasone/formoterol 250/10 bid.
- •4. Subjects currently using any fixed dose ICS/LABA other than Seretide® Accuhaler®.
- •5. Near fatal or life-threatening (including intubation) asthma, ACOS or COPD within one year of Visit 1.
- •6. Use of systemic (injectable or oral) corticosteroid medication within 4 weeks of Visit 1.
- •7. Evidence of a clinically unstable disease that, in the Investigator’s opinion, may confound between period comparisons or would put the Subject at risk through study participation.
- •8. A clinically significant upper or lower respiratory infection within 4 weeks prior to Visit 1.
- •9. Known or suspected sensitivity to study drug or excipients.
- •10. Current participation in a clinical study.
研究者
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