Staccato Loxapine Pulmonary Safety in Patients With Asthma

Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00890175

Enrollment

Registered

2009-04-29

Start date

2009-05-31

Completion date

2009-08-31

Last updated

2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Staccato loxapine

Brief summary

The purpose of this study is to assess the safety of 2 inhaled doses of Staccato Loxapine within a day in patients with asthma.

Interventions

DRUGInhaled loxapine @ 0 & 10 h

10 mg, 2 doses, 10 hours apart

DRUGInhaled placebo @ 2 & 10 hours

placebo, 2 doses, 10 hours apart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* History of mild to moderate persistent asthma for at least 6 months with pre-bronchodilator FEV1 ≥60% of predicted value.

Exclusion criteria

* History of COPD, or any other acute or chronic pulmonary disease

Design outcomes

Primary

Measure	Time frame
Change in FEV1 from baseline by spirometry	at each post-treatment time point (15 min to 34 hr)

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026