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Staccato Loxapine Pulmonary Safety in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Staccato Loxapine (Drug); Staccato Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Alexza Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Mildred D. Gottwald, PharmD, Study Director, Affiliation: Alexza Pharmaceuticals, Inc.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Change in FEV1 from baseline by spirometry

Secondary outcome:

Change in FVC from baseline by spirometry

Treatment emergent adverse events

Eligibility

Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Spartanburg Medical Research, Spartanburg, South Carolina 29303, United States
Additional Information

Starting date: June 2009
Last updated: August 28, 2009

Page last updated: August 23, 2015

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