Staccato Loxapine Pulmonary Safety in Patients With COPD

Alexza Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Inhaled Loxapine; Drug: Inhaled Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00889837

AMDC-004-108

13 April 2009

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and >15 pack-year history of cigarette smoking.

Exclusion criteria

• History of asthma, or any other acute or chronic pulmonary disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

53 participants in 2 patient groups, including a placebo group

Inhaled Loxapine

Experimental group

Description:

Staccato Loxapine, 10 mg doses x 2, 10 hours apart

Treatment:

Drug: Inhaled Loxapine

Inhaled Placebo

Placebo Comparator group

Description:

Staccato Placebo,inhalations x 2, 10 hours apart

Treatment:

Drug: Inhaled Placebo