Healthy
Conditions
Keywords
Healthy volunteers
Brief summary
The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.
Detailed description
The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.
Interventions
DRUGInhaled Placebo
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
DRUGInhaled Loxapine
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Sponsors
Alexza Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* nonsmoker subjects in good general health with normal spirometry at screening AND baseline
Exclusion criteria
* history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry | 17 post-treatment time points (15 min to 32 hr) | 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, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry | 17 post-treatment time points (15 min to 32 hr) | 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 |
Countries
United States
Participant flow
Recruitment details
Each investigator obtained approval from their IRB for their advertisements and other subject recruitment procedures
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Inhaled Placebo / Loxapine Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart | 15 |
| Inhaled Loxapine / Placebo Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 1 |
Baseline characteristics
| Characteristic | Inhaled Loxapine / Placebo | Inhaled Placebo / Loxapine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 28.7 years STANDARD_DEVIATION 9.75 | 31.4 years STANDARD_DEVIATION 13.65 | 30 years STANDARD_DEVIATION 11.74 |
| Region of Enrollment United States | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 27 |
| other Total, other adverse events | 5 / 29 | 16 / 27 |
| serious Total, serious adverse events | 1 / 29 | 0 / 27 |
Outcome results
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,
Time frame: 17 post-treatment time points (15 min to 32 hr)
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Inhaled Loxapine | The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry | -0.1042 liters |
| Inhaled Staccato Placebo | The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry | -0.1025 liters |
Comparison: The largest treatment difference (Loxapine - Placebo) in change in FEV1 from baseline by spirometry90% CI: [-0.028, 0.212]
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
Time frame: 17 post-treatment time points (15 min to 32 hr)
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Inhaled Loxapine | The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry | -0.271 liters |
| Inhaled Staccato Placebo | The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry | -0.149 liters |
90% CI: [-0.29, -0.019]