Staccato Loxapine Pulmonary Safety in Healthy Volunteers

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. Identifier: NCT00789360
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : May 5, 2009
Information provided by:
Alexza Pharmaceuticals, Inc.

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: Placebo -- Active Drug: Active -- Placebo 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 Type : Interventional  (Clinical Trial)
Estimated 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

Arm Intervention/treatment
Experimental: 1
Placebo -- Active
Drug: Placebo -- Active
Placebo followed by Active (Staccato Loxapine, 10 mg x 2)

Experimental: 2
Active -- Placebo
Drug: Active -- Placebo
Active (Staccato Loxapine, 10 mg x 2) followed by Placebo

Primary Outcome Measures :
  1. Change in FEV1 from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 32 hr) ]

Secondary Outcome Measures :
  1. Change in FVC from baseline by spirometry [ Time Frame: Post-treatment time points ]
  2. Treatment emergent adverse events [ Time Frame: Post-treatment time points ]

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): NCT00789360

United States, Massachusetts
Northeast Medical Research
North Dartmouth, Massachusetts, United States, 02747
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Principal Investigator: David S. Miller, MD Northeast Medical Research, North Dartmouth, MA

Responsible Party: Robert Fishman, MD., Vice President, Clinical Development, Alexza Pharmaceuticals, Inc. Identifier: NCT00789360     History of Changes
Other Study ID Numbers: AMDC-004-104
12 September 2008
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

Keywords provided by Alexza Pharmaceuticals, Inc.:
Healthy volunteers

Additional relevant MeSH terms:
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