Staccato Loxapine Pulmonary Safety in Patients With Asthma
This study has been completed.
Sponsor:
Alexza Pharmaceuticals, Inc.
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00890175
First received: April 27, 2009
Last updated: August 28, 2009
Last verified: August 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Staccato Loxapine Drug: Staccato Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma |
Resource links provided by NLM:
Further study details as provided by Alexza Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Change in FEV1 from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 34 hr) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in FVC from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 34 hr) ] [ Designated as safety issue: Yes ]
- Treatment emergent adverse events [ Time Frame: Post-treatment time points ] [ Designated as safety issue: Yes ]
| Enrollment: | 52 |
| Study Start Date: | May 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Staccato Loxapine
2 doses 10 hours apart
|
| Placebo Comparator: 2 |
Drug: Staccato Placebo
2 doses 10 hours apart
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890175
Locations
| United States, California | |
| 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. |
More Information
No publications provided
| Responsible Party: | Robert S. Fishman, MD, FCCP; Vice President, Medical Affairs, Alexza Pharmaceuitcals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00890175 History of Changes |
| Other Study ID Numbers: | AMDC-004-105, 10 April 2009 |
| Study First Received: | April 27, 2009 |
| Last Updated: | August 28, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alexza Pharmaceuticals, Inc.:
|
Asthma, Staccato loxapine |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Loxapine Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013