NCT00889837

Staccato Loxapine Pulmonary Safety in Patients With COPD

Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Inhaled Loxapine	Staccato Loxapine, 10 mg x 2 doses, 10 hours apart
DRUG	Inhaled Placebo	Staccato Placebo, inhalations x 2 , 10 hours apart

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-04-29
• Last updated: 2017-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study