Staccato Loxapine Pulmonary Safety in Patients With Asthma

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: NCT00890175

Recruitment Status : Completed

First Posted : April 29, 2009

Last Update Posted : March 15, 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 safety of 2 inhaled doses of Staccato Loxapine within a day in patients with asthma.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Inhaled loxapine @ 0 & 10 h Drug: Inhaled placebo @ 2 & 10 hours	Phase 1

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	52 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma
Study Start Date :	May 2009
Actual Primary Completion Date :	August 2009
Actual Study Completion Date :	August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Drug Information available for: Loxapine Loxapine succinate Loxapine hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Inhaled loxapine @ 0 & 10 h Inhalation of 10 mg of loxapine at 0 and 10 hours	Drug: Inhaled loxapine @ 0 & 10 h 10 mg, 2 doses, 10 hours apart Other Name: ADASUVE
Placebo Comparator: Inhaled placebo @ 2 & 10 hours Inhalation of 0 mg of loxapine (placebo) at 0 and 10 hours	Drug: Inhaled placebo @ 2 & 10 hours placebo, 2 doses, 10 hours apart Other Name: ADASUVE PLACEBO

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:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

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): NCT00890175

Locations

Layout table for location information

United States, California
Allergy and Asthma Medical Group & Research Center, A.P.C.
San Diego, California, United States, 92123

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:	NCT00890175
Other Study ID Numbers:	AMDC-004-105 10 April 2009
First Posted:	April 29, 2009 Key Record Dates
Last Update Posted:	March 15, 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

Keywords provided by Alexza Pharmaceuticals, Inc.:


Asthma, Staccato loxapine

Additional relevant MeSH terms:

Layout table for MeSH terms

Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases 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