Staccato Loxapine Pulmonary Safety in Patients With Asthma
Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma
2 other identifiers
interventional
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 asthma
Started May 2009
Shorter than P25 for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedMarch 15, 2017
August 1, 2009
3 months
April 27, 2009
March 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in FEV1 from baseline by spirometry
at each post-treatment time point (15 min to 34 hr)
Secondary Outcomes (2)
Change in FVC from baseline by spirometry
at each post-treatment time point (15 min to 34 hr)
Treatment emergent adverse events
Post-treatment time points
Study Arms (2)
Inhaled loxapine @ 0 & 10 h
EXPERIMENTALInhalation of 10 mg of loxapine at 0 and 10 hours
Inhaled placebo @ 2 & 10 hours
PLACEBO COMPARATORInhalation of 0 mg of loxapine (placebo) at 0 and 10 hours
Interventions
10 mg, 2 doses, 10 hours apart
placebo, 2 doses, 10 hours apart
Eligibility Criteria
You may qualify if:
- History of mild to moderate persistent asthma for at least 6 months with pre-bronchodilator FEV1 ≥60% of predicted value.
You may not qualify if:
- History of COPD, or any other acute or chronic pulmonary disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Allergy and Asthma Medical Group & Research Center, A.P.C.
San Diego, California, 92123, United States
Related Publications (1)
Gross N, Greos LS, Meltzer EO, Spangenthal S, Fishman RS, Spyker DA, Cassella JV. Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials. J Aerosol Med Pulm Drug Deliv. 2014 Dec;27(6):478-87. doi: 10.1089/jamp.2013.1114.
PMID: 24745666BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mildred D. Gottwald, PharmD
Alexza Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 29, 2009
Study Start
May 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
March 15, 2017
Record last verified: 2009-08
Data Sharing
- IPD Sharing
- Will share
IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com