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Real-World safety check for agitation inhaler

NCT ID NCT03513549

Knowledge-focused Sponsor: Alexza Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study observes the safety of ADASUVE (loxapine inhalation) in up to 10,000 adults with agitation from schizophrenia or bipolar I disorder. It tracks side effects in real-world emergency or inpatient settings. The study is observational, meaning no new treatment is given—just monitoring of routine use. It is currently suspended.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Loxapine (ADASUVE inhalation powder)
What this could lead to
If successful, this study could confirm that ADASUVE is safe for real-world use, supporting its continued availability for calming agitation in emergencies.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove effectiveness. The study is currently suspended, and results may be delayed or incomplete.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2014

Expected to finish

Sep 2027

An estimate. End dates often move.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients may be included in the study if they meet all of the following criteria: 1. The patient is a man or woman who is 18 years of age or older at time of enrollment. 2. 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.) 3. 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. Exclusion Criteria: There are no exclusion criteria for this study.

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Conditions

The condition(s) this trial relates to.

bipolar I disorder Psychomotor Agitation schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Agitation,psychomotor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pharmaceutical Research Associates, Inc

    Raleigh, North Carolina, 27612, United States

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