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Staccato Loxapine Pulmonary Safety in Patients With COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00889837
First received: April 27, 2009
Last updated: March 13, 2017
Last verified: August 2009
  Purpose
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 Intervention Phase
Chronic Obstructive Pulmonary Disease Drug: Inhaled Loxapine Drug: Inhaled Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider
Primary Purpose: Treatment
Official Title: Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


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 34 hr) ]

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

Enrollment: 53
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years   (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Publications:
Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00889837     History of Changes
Other Study ID Numbers: AMDC-004-108
13 April 2009
Study First Received: April 27, 2009
Last Updated: March 13, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 23, 2017