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Suspended due to low patient enrollment resulting from low commercial usage of Adasuve. Study continuation is impractical. Alexza has been in discussions with FDA on this matter.
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| Name | Class |
|---|---|
| Pharmaceutical Research Associates | OTHER |
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This postmarketing observational study will evaluate the safety of ADASUVE® in treating patients with agitation associated with schizophrenia or bipolar I disorder.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loxapine 10 MG | ADASUVE (loxapine) inhalation powder in a 10-milligram (mg) single-use oral inhaler. One dose in a 24-hour period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loxapine 10 MG | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient demographics | The secondary measure of this study is patient characteristics, including demographic characteristics, after administration of ADASUVE treatment in real-world clinical settings. | 24 hours |
| Patient baseline characteristics - medical history |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory objective - patient treatment satisfaction | 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. |
Inclusion Criteria:
Patients may be included in the study if they meet all of the following criteria:
Exclusion Criteria:
There are no exclusion criteria for this study.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc | Raleigh | North Carolina | 27612 | United States |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D008152 | Loxapine |
| ID | Term |
|---|---|
| D003989 | Dibenzoxazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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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. |
| 24 hours |
| Patient baseline characteristics - prior medications | 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. | 24 hours |
| 24 hours |
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |