Staccato Loxapine Pulmonary Safety in Patients With Asthma
Sponsor
Alexza Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00890175
Collaborator
(none)
52
1
2
3
17.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma
Study Start Date
:
May 1, 2009
Actual Primary Completion Date
:
Aug 1, 2009
Actual Study Completion Date
:
Aug 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Inhaled loxapine @ 0 & 10 h Inhalation of 10 mg of loxapine at 0 and 10 hours |
Drug: Inhaled loxapine @ 0 & 10 h
10 mg, 2 doses, 10 hours apart
Other Names:
|
| Placebo Comparator: Inhaled placebo @ 2 & 10 hours Inhalation of 0 mg of loxapine (placebo) at 0 and 10 hours |
Drug: Inhaled placebo @ 2 & 10 hours
placebo, 2 doses, 10 hours apart
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in FEV1 from baseline by spirometry [at each post-treatment time point (15 min to 34 hr)]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Allergy and Asthma Medical Group & Research Center, A.P.C. | San Diego | California | United States | 92123 |
Sponsors and Collaborators
- Alexza Pharmaceuticals, Inc.
Investigators
- Study Director: Mildred D. Gottwald, PharmD, Alexza Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00890175
Other Study ID Numbers:
- AMDC-004-105
- 10 April 2009
First Posted:
Apr 29, 2009
Last Update Posted:
Mar 15, 2017
Last Verified:
Aug 1, 2009
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alexza Pharmaceuticals, Inc.
Additional relevant MeSH terms: