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 spirometryTreatment 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
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