Staccato Loxapine Pulmonary Safety in Patients With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00889837

Recruitment Status : Completed

First Posted : April 29, 2009

Last Update Posted : March 14, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Alexza Pharmaceuticals, Inc.

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Inhaled Loxapine Drug: Inhaled Placebo	Phase 1

Detailed 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.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	53 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Care Provider)
Primary Purpose:	Treatment
Official Title:	Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease
Study Start Date :	June 2009
Actual Primary Completion Date :	August 2009
Actual Study Completion Date :	August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Loxapine Loxapine succinate Loxapine hydrochloride

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Inhaled Loxapine Staccato Loxapine, 10 mg doses x 2, 10 hours apart	Drug: Inhaled Loxapine Staccato Loxapine, 10 mg x 2 doses, 10 hours apart
Placebo Comparator: Inhaled Placebo Staccato Placebo,inhalations x 2, 10 hours apart	Drug: Inhaled Placebo Staccato Placebo, inhalations x 2 , 10 hours apart

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	40 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889837

Locations

Layout table for location information

United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators

Alexza Pharmaceuticals, Inc.

Investigators

Layout table for investigator information

Study Director:	Mildred D. Gottwald, PharmD	Alexza Pharmaceuticals, Inc.

More Information

Publications:

Gross N, Greos LS, Meltzer EO, Spangenthal S, Fishman RS, Spyker DA, Cassella JV. Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials. J Aerosol Med Pulm Drug Deliv. 2014 Dec;27(6):478-87. doi: 10.1089/jamp.2013.1114.

Layout table for additonal information

Responsible Party:	Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00889837
Other Study ID Numbers:	AMDC-004-108 13 April 2009
First Posted:	April 29, 2009 Key Record Dates
Last Update Posted:	March 14, 2017
Last Verified:	August 2009
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	Yes

Keywords provided by Alexza Pharmaceuticals, Inc.:


Staccato Loxapine COPD pulmonary safety

Additional relevant MeSH terms:

Layout table for MeSH terms

Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Chronic Disease Disease Attributes Pathologic Processes Loxapine 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

To Top