A Phase IV, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety of Self-administered ADASUVE® (Staccato Loxapine for Inhalation) in Agitated Patients Outside the Hospital Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 2
- 主要终点
- Serious adverse events and adverse events of special interest ( respiratory)
研究概览
简要总结
Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVE® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur.
详细描述
OVERALL STUDY DESIGN:
This is a phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional.
The Study will aim to include approximately 500 patients who have been previously treated with ADASUVE® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. An 'ADASUVE® responder' is defined as having a CGI-I score at 2 hours after administration of either a 1 (very much improved) or 2 (much improved). All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur.
Centers will be selected and qualified primarily based on their estimated number of eligible patients. The patients attending a hospital setting, such as Hospital Wards, Emergency Rooms, Day Care Units, Hospital Home-care units, or other Institutions for an agitation episode treatment will be recruited.
Site study staff will screen patients for potential participation on the clinical study at the time of presentation in a hospital setting for an on-going agitation episode during the recruitment period of 6 months, or retrospectively for a previous one episode within the 6 months prior to screening. The study staff will review the patient's medical records in detail to determine eligibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between the ages of 18-65 years, inclusive
- •Patients (or legal representative) willing and able to provide written Informed Consent Form.
- •Psychiatric patients already diagnosed of schizophrenia or bipolar disorder, according to the Diagnostic and Statistical Manual of Mental Disorders- IV, Diagnostic and Statistical Manual of Mental Disorders- V or International Code of Disease criteria.
- •Patients with an on-going agitation episode, or with a previous one within the 6 months prior to screening, attended and managed in the hospital setting.
- •Previously treated with ADASUVE® with a positive outcome (responders) according to (CGI-I) scale (defined as having a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)
- •Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease or emphysema).
- •Requirement of family or other caregiver support at study investigator criteria (defined as a patient's relative or caregiver (male or female) ≤ 80 year old, who spend ≥ 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures).
- •Availability of patient's medical records data about the previous treatment with ADASUVE® at hospital setting.
- •If a female is of childbearing potential and sexually active (except if female is surgically sterile or post-menopausal with history of no menses for at least 24 months), patient must be non-lactating and non-pregnant (with a negative pregnancy test result at baseline visit) and have to agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.
排除标准
- •Patient diagnosed with dementia.
- •Patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis).
- •Patients with a history of allergic reactions to loxapine or amoxapine
- •Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
- •Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device.
结局指标
主要结局
Serious adverse events and adverse events of special interest ( respiratory)
时间窗: one year
To assess the safety profile of self-administered ADASUVE® outside the hospital setting in a population of patients that are known ADASUVE® responders and well trained on the use of the product, with a primary focus on serious adverse events (SAEs) and adverse events of special interest (AESI) related to ADASUVE®, including respiratory events
次要结局
- time to improvement of the agitation episode after the self-administration of ADASUVE® outside the hospital setting.(one year)
- Prevalence of the medication for treating agitation episode in the hospital setting after self-administration of ADASUVE®.(one year)