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Staccato Loxapine Pulmonary Safety in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Information provided by:
Alexza Pharmaceuticals, Inc. Identifier:
First received: April 27, 2009
Last updated: August 28, 2009
Last verified: August 2009
The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Staccato Loxapine
Drug: Staccato Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in FEV1 from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 34 hr) ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Staccato Loxapine
2 doses 10 hours apart
Placebo Comparator: 2 Drug: Staccato Placebo
2 doses 10 hours apart


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00889837

United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Study Director: Mildred D. Gottwald, PharmD Alexza Pharmaceuticals, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert S. Fishman, Vice President, Clinical Development, Alexza Pharmaceuticals, Inc. Identifier: NCT00889837     History of Changes
Other Study ID Numbers: AMDC-004-108  13 April 2009 
Study First Received: April 27, 2009
Last Updated: August 28, 2009

Keywords provided by Alexza Pharmaceuticals, Inc.:
Staccato Loxapine
pulmonary safety

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on February 24, 2017