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Staccato Loxapine Pulmonary Safety in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00789360
First received: November 7, 2008
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Placebo -- Active
Drug: Active -- Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers

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 32 hr) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in FVC from baseline by spirometry [ Time Frame: Post-treatment time points ] [ Designated as safety issue: Yes ]
  • Treatment emergent adverse events [ Time Frame: Post-treatment time points ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789360

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

No publications provided

Responsible Party: Robert Fishman, MD., Vice President, Clinical Development, Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00789360     History of Changes
Other Study ID Numbers: AMDC-004-104, 12 September 2008
Study First Received: November 7, 2008
Last Updated: May 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:
Healthy volunteers

Additional relevant MeSH terms:
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