Back to resultsStaccato Loxapine Pulmonary Safety in Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Inhaled Loxapine
Inhaled Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Staccato Loxapine, COPD, pulmonary safety
Eligibility 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.
Sites / Locations
- Spartanburg Medical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Inhaled Loxapine
Inhaled Placebo
Arm Description
Staccato Loxapine, 10 mg doses x 2, 10 hours apart
Staccato Placebo,inhalations x 2, 10 hours apart
Outcomes
Primary Outcome Measures
Change in FEV1 from baseline by spirometry
Secondary Outcome Measures
Change in FVC from baseline by spirometry
Treatment emergent adverse events
Full Information
NCT ID
NCT00889837
First Posted
April 27, 2009
Last Updated
March 13, 2017
Sponsor
Alexza Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00889837
Brief Title
Staccato Loxapine Pulmonary Safety in Patients With COPD
Official Title
Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexza Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Staccato Loxapine, COPD, pulmonary safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhaled Loxapine
Arm Type
Experimental
Arm Description
Staccato Loxapine, 10 mg doses x 2, 10 hours apart
Arm Title
Inhaled Placebo
Arm Type
Placebo Comparator
Arm Description
Staccato Placebo,inhalations x 2, 10 hours apart
Intervention Type
Drug
Intervention Name(s)
Inhaled Loxapine
Intervention Description
Staccato Loxapine, 10 mg x 2 doses, 10 hours apart
Intervention Type
Drug
Intervention Name(s)
Inhaled Placebo
Intervention Description
Staccato Placebo, inhalations x 2 , 10 hours apart
Primary Outcome Measure Information:
Title
Change in FEV1 from baseline by spirometry
Time Frame
at each post-treatment time point (15 min to 34 hr)
Secondary Outcome Measure Information:
Title
Change in FVC from baseline by spirometry
Time Frame
at each post-treatment time point (15 min to 34 hr)
Title
Treatment emergent adverse events
Time Frame
Post-treatment time points
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mildred D. Gottwald, PharmD
Organizational Affiliation
Alexza Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Citations:
PubMed Identifier
24745666
Citation
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.
Results Reference
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Staccato Loxapine Pulmonary Safety in Patients With COPD
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