Staccato Loxapine Pulmonary Safety in Patients With Asthma

Alexza Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Inhaled placebo @ 2 & 10 hours; Drug: Inhaled loxapine @ 0 & 10 h

Study type: Interventional

Funder types: Industry

Identifiers

NCT00890175

10 April 2009

AMDC-004-105

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Inhaled loxapine @ 0 & 10 h

Experimental group

Description:

Inhalation of 10 mg of loxapine at 0 and 10 hours

Treatment:

Drug: Inhaled loxapine @ 0 & 10 h

Inhaled placebo @ 2 & 10 hours

Placebo Comparator group

Description:

Inhalation of 0 mg of loxapine (placebo) at 0 and 10 hours

Treatment:

Drug: Inhaled placebo @ 2 & 10 hours