Staccato Loxapine Pulmonary Safety in Patients With Asthma
Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
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 safety of 2 inhaled doses of Staccato Loxapine
within a day in patients with asthma.
Clinical Details
Official title: Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- History of mild to moderate persistent asthma for at least 6 months with
pre-bronchodilator FEV1 ≥60% of predicted value.
Exclusion Criteria:
- History of COPD, or any other acute or chronic pulmonary disease
Locations and Contacts
Allergy and Asthma Medical Group & Research Center, A.P.C., San Diego, California 92123, United States
Additional Information
Starting date: May 2009
Last updated: August 28, 2009
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