Staccato Loxapine Pulmonary Safety in Patients With COPD

March 13, 2017 updated by: Alexza Pharmaceuticals, Inc.

Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease

The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.

Study Type

Interventional

Enrollment (Actual)

53

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
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg 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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and >15 pack-year history of cigarette smoking.

Exclusion Criteria:

  • History of asthma, or any other acute or chronic pulmonary disease.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled Loxapine
Staccato Loxapine, 10 mg doses x 2, 10 hours apart
Drug: Inhaled Loxapine
Staccato Loxapine, 10 mg x 2 doses, 10 hours apart
Placebo Comparator: Inhaled Placebo
Staccato Placebo,inhalations x 2, 10 hours apart
Drug: Inhaled Placebo
Staccato Placebo, inhalations x 2 , 10 hours apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in FEV1 from baseline by spirometry
Time Frame: at each post-treatment time point (15 min to 34 hr)
at each post-treatment time point (15 min to 34 hr)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in FVC from baseline by spirometry
Time Frame: at each post-treatment time point (15 min to 34 hr)
at each post-treatment time point (15 min to 34 hr)
Treatment emergent adverse events
Time Frame: Post-treatment time points
Post-treatment time points

Collaborators and Investigators

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

Sponsor

Alexza Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMDC-004-108
  • 13 April 2009

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

product manufactured in and exported from the U.S.

Yes

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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