Phase 1 Completed N=30 Randomized Quadruple-blind Treatment

Staccato Loxapine Pulmonary Safety in Healthy Volunteers

Healthy

Source: ClinicalTrials.gov NCT00789360 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Mar 2019

Primary outcomePrimary: The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry — -0.1042; -0.1025 liters

Summary

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry	-0.1042; -0.1025	—
SECONDARY The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry	-0.271; -0.149	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00789360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.