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Staccato Loxapine Pulmonary Safety in Patients With COPD

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ClinicalTrials.gov Identifier: NCT00889837
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Inhaled Loxapine Drug: Inhaled Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease
Study Start Date : June 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in FEV1 from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 34 hr) ]

Secondary Outcome Measures :
  1. Change in FVC from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 34 hr) ]
  2. Treatment emergent adverse events [ Time Frame: Post-treatment time points ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT00889837


Locations
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
Study Director: Mildred D. Gottwald, PharmD Alexza Pharmaceuticals, Inc.

Publications:
Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00889837     History of Changes
Other Study ID Numbers: AMDC-004-108
13 April 2009
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: August 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

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

Keywords provided by Alexza Pharmaceuticals, Inc.:
Staccato Loxapine
COPD
pulmonary safety

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
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