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Staccato Loxapine Pulmonary Safety in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00789360
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Condition or disease Intervention/treatment Phase
Healthy Drug: Inhaled Placebo Drug: Inhaled Loxapine Phase 1

Detailed Description:
The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers
Study Start Date : November 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Inhaled Placebo crossed over to Inhaled Loxapine
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart
 Drug: Inhaled Placebo
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart

Drug: Inhaled Loxapine
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Experimental: Inhaled Loxapine crossed over to Inhaled Placebo
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;
 Drug: Inhaled Placebo
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart

Drug: Inhaled Loxapine
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart


Outcome Measures
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Primary Outcome Measures :
  1. The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry [ Time Frame: 17 post-treatment time points (15 min to 32 hr) ]
    The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,


Secondary Outcome Measures :
  1. The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry [ Time Frame: 17 post-treatment time points (15 min to 32 hr) ]
    The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FVC Change from Same-Period Baseline


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

Inclusion Criteria:

  • nonsmoker subjects in good general health with normal spirometry at screening AND baseline

Exclusion Criteria:

  • history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use
Contacts and Locations
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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): NCT00789360


Locations
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United States, Massachusetts
Northeast Medical Research
North Dartmouth, Massachusetts, United States, 02747
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
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Principal Investigator: David S. Miller, MD Northeast Medical Research, North Dartmouth, MA
More Information
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Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00789360    
Other Study ID Numbers: AMDC-004-104
12 September 2008
First Posted: November 11, 2008    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019
Last Verified: May 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexza Pharmaceuticals, Inc.:
Healthy volunteers
Additional relevant MeSH terms:
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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