Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

NCT03513549 | Suspended FDA Drug

• 1 other identifier: TV571-CNS-40036
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

This postmarketing observational study will evaluate the safety of ADASUVE® in treating patients with agitation associated with schizophrenia or bipolar I disorder.

Conditions

Agitation,Psychomotor

Keywords

Agitation; Schizophrenia; Bipolar I disorder

Outcome Measures

Primary Outcomes (1)

• Evaluating frequency and nature of adverse events, serious adverse events and respiratory adverse events of special interest (AESIs) after administration of ADASUVE treatment in real-world clinical settings

  Safety will be assessed by evaluating adverse events, serious adverse events, and respiratory AESIs within the study follow-up period after administration of ADASUVE treatment in real-world clinical settings.

  24 hours

Secondary Outcomes (3)

• Patient demographics

  24 hours

• Patient baseline characteristics - medical history

  24 hours

• Patient baseline characteristics - prior medications

  24 hours

Other Outcomes (1)

• Exploratory objective - patient treatment satisfaction

  24 hours

Study Arms (1)

Loxapine 10 MG

ADASUVE (loxapine) inhalation powder in a 10-milligram (mg) single-use oral inhaler. One dose in a 24-hour period.

Drug: Loxapine 10 MG

Interventions

Loxapine 10 MG DRUG

Also known as: ADASUVE (loxapine) inhalation powder, NDA 022549

Loxapine 10 MG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of a non-randomized cohort of approximately 10000 adult men and women who have agitation associated with schizophrenia or bipolar I disorder (naïve and non-naïve to ADASUVE treatment), as determined by the treating health care provider, and who meet the eligibility criteria.

You may qualify if:

• Patients may be included in the study if they meet all of the following criteria:
• The patient is a man or woman who is 18 years of age or older at time of enrollment.
• The patient is receiving ADASUVE for agitation in a medical or psychiatric emergency setting or in a psychiatric inpatient setting. (Note: Patients with a prior history of treatment with ADASUVE may also be included in the study.)
• The patient (or caregiver or legally authorized representative) is willing and able to provide written informed consent (and assent, where applicable) after administration of ADASUVE treatment.

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead
• Pharmaceutical Research Associates: collaborator

Study Sites (1)

Pharmaceutical Research Associates, Inc

Raleigh, North Carolina, 27612, United States

Location

MeSH Terms

Conditions

Psychomotor Agitation; Schizophrenia

Interventions

Loxapine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzoxazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 1, 2018
• Study Start: November 4, 2014
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)