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

A Phase IV, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety of self-administered ADASUVE(R) (Staccato loxapine for inhalation) in Agitated Patients outside the hospital setting

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003331-36-AT

Enrollment

500

Registered

2015-12-04

Start date

2016-03-16

Completion date

Unknown

Last updated

2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder MedDRA version: 20.0 Level: PT Classification code 10001497 Term: Agitation System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: ADASUVE® Pharmaceutical Form: Inhalation powder, pre-dispensed INN or Proposed INN: loxapine CAS Number: 1977-10-2 Other descriptive name: LOXAPINE Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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 (mild or moderate), 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) or equivalent clinical evaluation at the discretion of the investigator and they have not developed bronchospasm after previous administration. 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. Patient and/or caregiver/family able to: a. understand and follow a specific training for the administration of ADASUVE® outside the hospital setting, b. identify/detect a respiratory problem c. use of a 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: - To evaluate the time to improvement of the agitation episode after the self-adminsitration of ADASUVE® outside the hospital setting. - To analyse the patient-rated Clinical Global Impression-Improvement (CGI-I) scores up to 2 hours after the initial ADASUVE® self-administered dose outside of a hospital setting. - To evaluate the treatment satisfaction in ADASUVE® responders after the initial self-administered dose outside the hospital setting. - To describe the practice patterns for treating a worsening or no improvement of an agitation episode in the hospital setting after self-administration of ADASUVE®. - To analyse the degree of concordance between the patient/family member-caregiver and the physician in the diagnosis of the agitation episode/ administration of ADASUVE®. - To describe the patient profile and post-treatment outcomes of agitated patients/caregiver treated with ADASUVE® outside the hospital setting according to their level of agitation.;Primary end point(s): The primary endpoint of the study is to assess the frequency of AEs related to ADASUVE®, with focus on SAEs and AESIs (including respiratory events) following the self-administration of ADASUVE® outside of a hospital setting.;Timepoint(s) of evaluation of this end point: Following the self-administration of ADASUVE outside of a hospital setting.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: - To evaluate the time to improvement of the agitation episode after the self-adminsitration of ADASUVE® outside the hospital setting. - To analyse the patient-rated Clinical Global Impression-Improvement (CGI-I) scores up to 2 hours after the initial ADASUVE® self-administered dose outside of a hospital setting. - To evaluate the treatment satisfaction in ADASUVE® responders after the initial self-administered dose outside the hospital setting. - To describe the practice patterns for treating a worsening or no improvement of an agitation episode in the hospital setting after self-administration of ADASUVE®. - To analyse the degree of concordance between the patient/family member-caregiver and the physician in the diagnosis of the agitation episode/ administration of ADASUVE®. - To describe the patient profile and post-treatment outcomes of agitated patients/caregiver treated with ADASUVE® outside the hospital setting according to their level of agitation.;Primary end point(s): The primary endpoint of the study is to assess the frequency of AEs related to ADASUVE®, with focus on SAEs and AESIs (including respiratory events) following the self-administration of ADASUVE® outside of a hospital setting.;Timepoint(s) of evaluation of this end point: Following the self-administration of ADASUVE outside of a hospital setting.

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Secondary

Measure	Time frame
Secondary end point(s): - Incidence of other AEs-non respiratory AESIs related to ADASUVE® self-administration treatment outside the hospital setting. - Incidence of AEs, SAEs, AESIs and non-respiratory AESIs related to the second dose of ADASUVE® administered at the hospital setting (only in cases with a 2nd dose administration). - Time to onset of improvement of the current episode of agitation following the ADASUVE® self-administration outside the hospital setting. - Absolute CGI-I scores up to 2 hours after drug self-administration outside of a hospital setting. - Percentage of ADASUVE® responders, calculated as the proportion of patients who achieved a score of 1 ('very much improved') or 2 ('much improved') in CGI-Improvement scale at 2 hours after selfadministration of ADASUVE®. Patients' treatment satisfaction in ADASUVE® responders measured with a 5-point Likert scale at the end of the 24-74h follow-up period. - Patients’ treatment satisfaction in ADASUVE® responders measured with a 5-point Likert scale at the end of the 24-74h follow-up period. - Description of all anti-agitation medications administered at hospital setting (2nd dose of ADASUVE® or other treatments) for treating a worsening or no improvement of an agitation episode after self-administration of ADASUVE® outside the hospital setting. - Percentage of observed concordance and the degree of concordance between the patient/family member-caregiver and physician (clinical criteria) in identifying the severity of the agitation episode/ administration of ADASUVE®. - Description of patients and family members/ caregivers´ demographics, and clinical characteristics of agitated patients treated with ADASUVE® outside the hospital setting. - Description of possible differences in demographic and clinical profiles (diagnosis, disease status and agitation episode characteristics including symptoms of agitation), and post-treatment ADASUVE® outcomes among mild and moderate levels of agi	—

Measure

Time frame

Secondary end point(s): - Incidence of other AEs-non respiratory AESIs related to ADASUVE® self-administration treatment outside the hospital setting. - Incidence of AEs, SAEs, AESIs and non-respiratory AESIs related to the second dose of ADASUVE® administered at the hospital setting (only in cases with a 2nd dose administration). - Time to onset of improvement of the current episode of agitation following the ADASUVE® self-administration outside the hospital setting. - Absolute CGI-I scores up to 2 hours after drug self-administration outside of a hospital setting. - Percentage of ADASUVE® responders, calculated as the proportion of patients who achieved a score of 1 ('very much improved') or 2 ('much improved') in CGI-Improvement scale at 2 hours after selfadministration of ADASUVE®. Patients' treatment satisfaction in ADASUVE® responders measured with a 5-point Likert scale at the end of the 24-74h follow-up period. - Patients’ treatment satisfaction in ADASUVE® responders measured with a 5-point Likert scale at the end of the 24-74h follow-up period. - Description of all anti-agitation medications administered at hospital setting (2nd dose of ADASUVE® or other treatments) for treating a worsening or no improvement of an agitation episode after self-administration of ADASUVE® outside the hospital setting. - Percentage of observed concordance and the degree of concordance between the patient/family member-caregiver and physician (clinical criteria) in identifying the severity of the agitation episode/ administration of ADASUVE®. - Description of patients and family members/ caregivers´ demographics, and clinical characteristics of agitated patients treated with ADASUVE® outside the hospital setting. - Description of possible differences in demographic and clinical profiles (diagnosis, disease status and agitation episode characteristics including symptoms of agitation), and post-treatment ADASUVE® outcomes among mild and moderate levels of agi

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Countries

Austria, Norway

Contacts

Public ContactThais Baleeiro Teixeira

FERRER INTERNACIONAL SA

tbaleeiro@ferrer.com0034935082966

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 23, 2026