Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
Study Details
Study Description
Brief Summary
This postmarketing observational study will evaluate the safety of ADASUVE® in treating patients with agitation associated with schizophrenia or bipolar I disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a multicenter, prospective, observational study conducted to evaluate the safety of ADASUVE treatment when used in real-world clinical setting in patients with agitation associated with schizophrenia or bipolar I disorder.
The primary objective of the study is to assess the safety of ADASUVE treatment in real-world clinical settings.
The secondary objective of the study is to describe the characteristics of patients, including demographic and baseline characteristics, after administration of ADASUVE treatment in real-world clinical settings.
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 [24 hours]
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.
Secondary Outcome Measures
- Patient demographics [24 hours]
The secondary measure of this study is patient characteristics, including demographic characteristics, after administration of ADASUVE treatment in real-world clinical settings.
- Patient baseline characteristics - medical history [24 hours]
The secondary measure of this study is patient characteristics, including baseline characteristic of medical history, after administration of ADASUVE treatment in real-world clinical settings.
- Patient baseline characteristics - prior medications [24 hours]
The secondary measure of this study is patient characteristics, including baseline characteristic of prior medications, after administration of ADASUVE treatment in real-world clinical settings.
Other Outcome Measures
- Exploratory objective - patient treatment satisfaction [24 hours]
The exploratory objective of the study is to assess patient perception of effectiveness (ranging from extremely dissatisfied to extremely satisfied), convenience (ranging from extremely inconvenient to extremely convenient), and overall satisfaction (ranging from extremely dissatisfied to extremely satisfied) using a modified Treatment Satisfaction Questionnaire for Medication (TSQM) after administration of ADASUVE treatment in real-world clinical settings. The TSQM is a modified version of the original TSQM version 1.4, a widely used generic measure to assess treatment satisfaction with medication. Scores range from 0 to 100, with higher scores representing higher satisfaction.
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients may be included in the study if they meet all of the following criteria:
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The patient is a man or woman who is 18 years of age or older at time of enrollment.
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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.)
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pharmaceutical Research Associates, Inc | Raleigh | North Carolina | United States | 27612 |
Sponsors and Collaborators
- Alexza Pharmaceuticals, Inc.
- Pharmaceutical Research Associates
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TV571-CNS-40036