Staccato Loxapine Pulmonary Safety in Healthy Volunteers

November 18, 2018 updated by: Alexza Pharmaceuticals, Inc.

Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
17 post-treatment time points (15 min to 32 hr)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
17 post-treatment time points (15 min to 32 hr)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexza Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: David S. Miller, MD, Northeast Medical Research, North Dartmouth, MA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Actual)

March 11, 2019

Last Update Submitted That Met QC Criteria

November 18, 2018

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMDC-004-104
  • 12 September 2008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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