Staccato Loxapine Pulmonary Safety in Patients With Asthma

Alexza Pharmaceuticals, Inc.52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

Inhaled loxapine @ 0 & 10 hDRUG

10 mg, 2 doses, 10 hours apart

Inhaled placebo @ 2 & 10 hoursDRUG

placebo, 2 doses, 10 hours apart

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Allergy and Asthma Medical Group & Research Center, A.P.C.

San Diego, California, United States

Outcomes

Primary Outcomes

Change in FEV1 from baseline by spirometry

Time frame: at each post-treatment time point (15 min to 34 hr)

Secondary Outcomes

Change in FVC from baseline by spirometry

Time frame: at each post-treatment time point (15 min to 34 hr)

Treatment emergent adverse events

Time frame: Post-treatment time points

Data from ClinicalTrials.gov

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