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| ID | Type | Description | Link |
|---|---|---|---|
| 13 April 2009 |
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The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD.
To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Loxapine | Experimental | Staccato Loxapine, 10 mg doses x 2, 10 hours apart |
|
| Inhaled Placebo | Placebo Comparator | Staccato Placebo,inhalations x 2, 10 hours apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Loxapine | Drug | Staccato Loxapine, 10 mg x 2 doses, 10 hours apart |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 from baseline by spirometry | at each post-treatment time point (15 min to 34 hr) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FVC from baseline by spirometry | at each post-treatment time point (15 min to 34 hr) | |
| Treatment emergent adverse events | Post-treatment time points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mildred D. Gottwald, PharmD | Alexza Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24745666 | Background | Gross N, Greos LS, Meltzer EO, Spangenthal S, Fishman RS, Spyker DA, Cassella JV. Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials. J Aerosol Med Pulm Drug Deliv. 2014 Dec;27(6):478-87. doi: 10.1089/jamp.2013.1114. |
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IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Inhaled Placebo |
| Drug |
Staccato Placebo, inhalations x 2 , 10 hours apart |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |