A Clinical Trial to Evaluate the Safety of self-administered ADASUVE (Staccato loxapine for inhalation) in Agitated Patients outside the hospital setting.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 322

Inclusion Criteria

1. Male and female patients between the ages of 18-65 years, inclusive
2. Patients (or legal representative) willing and able to provide written Informed Consent Form.
3. Psychiatric patients already diagnosed of schizophrenia or bipolar disorder (according DSM-IV-TR, DSM-V or ICD-10 criteria).
4. 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.
5. 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)
6. 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 [COPD] or emphysema).
7. Able to:
a. understand and follow a specific training for the self-administration of ADASUVE® outside the hospital setting,
b. identify/detect a respiratory problem
c. use of an bronchodilator if needed
8. 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).
9. Availability of patient’s medical records data about the previous treatment with ADASUVE® at hospital setting.
10. 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.
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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient diagnosed with dementia.
2. 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).
3. Patients with a history of allergic reactions to loxapine or amoxapine
4. Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
5. Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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