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

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00889837
First received: April 27, 2009
Last updated: August 28, 2009
Last verified: August 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in FVC from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 34 hr) ] [ Designated as safety issue: Yes ]
  • Treatment emergent adverse events [ Time Frame: Post-treatment time points ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889837

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

No publications provided

Responsible Party: Robert S. Fishman, Vice President, Clinical Development, Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Loxapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013