Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 12 September 2008 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.
The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Placebo crossed over to Inhaled Loxapine | Experimental | Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart |
|
| Inhaled Loxapine crossed over to Inhaled Placebo | Experimental | Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Placebo | Drug | Inhaled Staccato Placebo, 2 inhalations, 8 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry | The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline, | 17 post-treatment time points (15 min to 32 hr) |
| Measure | Description | Time Frame |
|---|---|---|
| The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry | The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FVC Change from Same-Period Baseline | 17 post-treatment time points (15 min to 32 hr) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David S. Miller, MD | Northeast Medical Research, North Dartmouth, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Medical Research | North Dartmouth | Massachusetts | 02747 | United States |
IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Not provided
Not provided
Not provided
Not provided
At screening and before administration of Dose 1 in each treatment period, the following were confirmed: forced expiratory volume in 1 second (FEV1) ≥85% of predicted, forced vital capacity (FVC) ≥85% of predicted, and oxygen saturation by pulse oximetry (SpO2)
≥95% on room air.
Each investigator obtained approval from their IRB for their advertisements and other subject recruitment procedures
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Placebo / Loxapine | Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart |
| FG001 | Inhaled Loxapine / Placebo | Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Placebo / Loxapine | Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart |
| BG001 | Inhaled Loxapine / Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry | The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline, | Crossover Spirometry Population (all subjects receiving both inhaled loxapine and inhaled placebo) LSM and CI statistics were based on the individual (within subject) differences between loxapine and placebo exposures | Posted | Least Squares Mean | 90% Confidence Interval | liters | 17 post-treatment time points (15 min to 32 hr) |
|
Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 16 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaled Placebo | Inhaled Staccato Placebo, 2 inhalations, 8 hours apart Inhaled Placebo: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive VP, Research & Development, Regulatory & Quality | Alexza Pharmaceuticals, Inc | 650.944.7071 | ClinicalTrialsInfo@alexza.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Inhaled Loxapine | Drug | Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart |
|
Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart |
|
|
|
| Secondary | The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry | The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FVC Change from Same-Period Baseline | Crossover Spirometry Population (all subjects receiving both inhaled loxapine and inhaled placebo) LSM and CI statistics were based on the individual (within subject) differences between loxapine and placebo exposures | Posted | Least Squares Mean | 90% Confidence Interval | liters | 17 post-treatment time points (15 min to 32 hr) |
|
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| 5 |
| 29 |
| EG001 | Inhaled Loxapine | Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart Inhaled Loxapine: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart | 0 | 27 | 0 | 27 | 16 | 27 |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided