Trial Outcomes & Findings for Staccato Loxapine Pulmonary Safety in Healthy Volunteers (NCT NCT00789360)
NCT ID: NCT00789360
Last Updated: 2019-03-11
Results Overview
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,
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
17 post-treatment time points (15 min to 32 hr)
Results posted on
2019-03-11
Participant Flow
Each investigator obtained approval from their IRB for their advertisements and other subject recruitment procedures
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.
Participant milestones
| Measure |
Inhaled Placebo / Loxapine
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
|
Inhaled Loxapine / Placebo
Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Inhaled Placebo / Loxapine
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
|
Inhaled Loxapine / Placebo
Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
Baseline Characteristics
Staccato Loxapine Pulmonary Safety in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Inhaled Placebo / Loxapine
n=15 Participants
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
|
Inhaled Loxapine / Placebo
n=15 Participants
Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 13.65 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 9.75 • n=7 Participants
|
30 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
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,
Outcome measures
| Measure |
Inhaled Loxapine
n=23 Participants
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
|
Inhaled Staccato Placebo
n=25 Participants
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
|
|---|---|---|
|
The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry
|
-0.1042 liters
Interval -0.1776 to -0.031
|
-0.1025 liters
Interval -0.18099 to -0.02393
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Inhaled Loxapine
n=25 Participants
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
|
Inhaled Staccato Placebo
n=25 Participants
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
|
|---|---|---|
|
The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry
|
-0.271 liters
Interval -0.37 to -0.172
|
-0.149 liters
Interval -0.264 to -0.035
|
Adverse Events
Inhaled Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Inhaled Loxapine
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Placebo
n=29 participants at risk
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
Inhaled Placebo: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
|
Inhaled Loxapine
n=27 participants at risk
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Inhaled Loxapine: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
|
|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
3.4%
1/29 • Number of events 1 • 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
|
0.00%
0/27 • 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
|
Other adverse events
| Measure |
Inhaled Placebo
n=29 participants at risk
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
Inhaled Placebo: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
|
Inhaled Loxapine
n=27 participants at risk
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Inhaled Loxapine: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
|
|---|---|---|
|
Gastrointestinal disorders
Dysgeusia
|
3.4%
1/29 • Number of events 1 • 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
|
44.4%
12/27 • Number of events 12 • 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
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • 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
|
7.4%
2/27 • Number of events 2 • 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
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • 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
|
7.4%
2/27 • Number of events 2 • 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
|
|
Nervous system disorders
Headache
|
13.8%
4/29 • Number of events 4 • 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
|
7.4%
2/27 • Number of events 2 • 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
|
Additional Information
Executive VP, Research & Development, Regulatory & Quality
Alexza Pharmaceuticals, Inc
Phone: 650.944.7071
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60