Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
Primary Purpose
Asthma, Chronic Obstructive Pulmonary Disease, COPD
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Levalbuterol HFA MDI with top mounted actuation indicator
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring top mounted, actuation indicator, Asthma, COPD, Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Subject must have a documented diagnosis of asthma or COPD for a minimum of 6 months.
- Subject must have stable baseline asthma or COPD and have been using a beta-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months.
- Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
Exclusion Criteria:
- Female subject who is pregnant or lactating.
- Subject who has a history of hospitalization for asthma or COPD within 45 days.
- Subject with currently diagnosed life-threatening asthma or COPD, defined as a history of asthma or COPD episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior.
- Subject with supplemental oxygen use
- Subject with a history of cancer
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders that currently are not well controlled by medication.
- Subject with asthma with a greater than 10-pack per year history of cigarette smoking or use of any tobacco products within 6 months.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Levalbuterol HFA MDI with top mounted actuation indicator
Outcomes
Primary Outcome Measures
The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.
Secondary Outcome Measures
Full Information
NCT ID
NCT00583986
First Posted
December 21, 2007
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00583986
Brief Title
Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
Official Title
A Study to Determine the Reliability of a Top Mount Actuation Indicator When Used With Levalbuterol Tartrate HFA MDI in Adult and Pediatric Subjects With Asthma or Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.
Detailed Description
This is an open-label, multicenter, TMAI study with Levalbuterol HFA MDI in adult and pediatric subjects with asthma or COPD. Period I: One week, open-label, run-in period during which subjects must have asthma or COPD symptoms requiring use of, as needed, Levalbuterol HFA MDI(without TMAI) on at least half of the days [4-12 actuations on a single day]. Period II: Nine week, open-label period during which subjects will use the Levalbuterol HFA MDI with TMAI PRN. The total study duration for a subject will not exceed 10 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease, COPD
Keywords
top mounted, actuation indicator, Asthma, COPD, Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Levalbuterol HFA MDI with top mounted actuation indicator
Intervention Type
Drug
Intervention Name(s)
Levalbuterol HFA MDI with top mounted actuation indicator
Other Intervention Name(s)
Xopenex HFA®
Intervention Description
Levalbuterol HFA MDA with top mounted actuation indicator
Primary Outcome Measure Information:
Title
The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must have a documented diagnosis of asthma or COPD for a minimum of 6 months.
Subject must have stable baseline asthma or COPD and have been using a beta-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months.
Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
Exclusion Criteria:
Female subject who is pregnant or lactating.
Subject who has a history of hospitalization for asthma or COPD within 45 days.
Subject with currently diagnosed life-threatening asthma or COPD, defined as a history of asthma or COPD episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior.
Subject with supplemental oxygen use
Subject with a history of cancer
Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders that currently are not well controlled by medication.
Subject with asthma with a greater than 10-pack per year history of cigarette smoking or use of any tobacco products within 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hanrahan, M.D.
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Chair
Facility Information:
City
Encinatas
State/Province
California
ZIP/Postal Code
92024
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
City
Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
City
Orange County
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
City
Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
City
Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.xopenex.com/about/patient-instructions.html
Description
Patient's Instructions for Use
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Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
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