EUCTR2021-001449-11-IT进行中（未招募）1 期
An exploratory, double-blind, randomised, multicenter, psychopharmacological study in adult patients with moderate to severe asthma to compare two pressurised Metered-Dose Inhalers (pMDIs) on patients’ perception of asthma symptoms. - FEE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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.Subject’s and/or subject legal representative’s written informed consent obtained prior to any study related procedure.
- •2.Age: >=18 and <=75 years of age.
- •3.Diagnosis of asthma: Established diagnosis of permanent asthma for at least 6 months prior to screening/randomisation visit, with documented history of variable respiratory symptoms and confirmed variable expiratory airflow limitation according to the description in the Box 1-2 of the 2020 GINA Report.
- •4.Current asthma therapy: Subject on maintenance therapy treated by Foster® (CHF1535 100/6 µg pMDI) for at least 6 months prior to screening/randomisation visit (A subject under Foster® MART indication is eligible).
- •5.Asthma control: Asthma Control Test (ACT) >= 20 at screening/randomisation visit.
- •6.Ability to comply with the protocol: Subject must have a cooperative attitude and the ability to be trained to use correctly the diary and answer the Visual Analogue Scale (VAS), to be able to perform the required outcomes measurements and the ability to understand the risks involved.
- •7.Subject willing and able to use their electronic device to download the application to fill in the study e-diary and to enable video communication.
- •8.Female subjects:
- •a.WOCBP fulfilling one of the following criteria:
- •i.WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until Visit 4 or
- •ii.WOCBP with non-fertile male partners (contraception is not required in this case).
- •For the definition of WOCBP and of fertile men and the list of highly effective birth control methods, refer to Appendix 4.
- •b.Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile, as per definitions given in Appendix 4). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator’s request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Pregnant or lactacting woman
- •2. History of 'at risk' asthma: history of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the investigator may place the subject at undue risk
- •3. Recent exacerbation: asthma exacerbation requiring systemic corticosteroids or emergency room admission or hospitalization within 4 weeks prior to screening/randomization visit
- •4. Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine.
- •5. Asthma requiring more than 1 inhaler for manteinance treatment and than more 1 inhaler for reliever treatment
- •6. Asthma requiring use of biologics: asthma subject treated with chronic systemic corticosteroids or anti-IgE or other monoclonal or polyclonal antibodies.
- •7. Respiratory disorders rather than asthma
- •8. Subject with lower respiratory tract infection that required use of antibiotics within 4-6 weeks prior to screening/randomization
- •9. Current smoker or ex-smoker with a smoking current use/history of >= 10 pack-years
- •10. Cardiovascular disease
- •11. Other concurrent disease
- •12. Subject with a known or suspected history of alcohol and/or substance drug abuse within 12 months prior to screening/randomisation visit
- •13. Subject who has received any investigational drug within the last 30 days (60 days for biologics) or a more appropriate time as determinated by the investigator
- •14. Contra-indications to Foster®
- •15. History of hypersensitivity to Foster® or any of its components or a history of other allergy that in the opinion of the investigator controindicates the subject's participation
- •16. Subject mentally or legally incapacitated
- •17. Blind, colour blind subject or any other dyschromatopsia
- •18. Known psychiatric disorders that may interfere with successful completion of this protocol
研究者
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