Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
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
1 other identifier
interventional
150
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Sep 2005
Shorter than P25 for phase_3 asthma
26 active sites
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
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 2, 2008
CompletedFebruary 22, 2012
February 1, 2012
4 months
December 21, 2007
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.
10 weeks
Study Arms (1)
1
EXPERIMENTALLevalbuterol HFA MDI with top mounted actuation indicator
Interventions
Levalbuterol HFA MDA with top mounted actuation indicator
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Encinatas, California, 92024, United States
Unknown Facility
Huntington Beach, California, 92647, United States
Unknown Facility
Mesa, California, 92626, United States
Unknown Facility
Orange County, California, 92868, United States
Unknown Facility
Riverside, California, 92506, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
San Jose, California, 95128, United States
Unknown Facility
Viejo, California, 92691, United States
Unknown Facility
Walnut Creek, California, 94596, United States
Unknown Facility
Tamarac, Florida, 33321, United States
Unknown Facility
Russells Mills, Massachusetts, 02747, United States
Unknown Facility
Commack, New York, 11725, United States
Unknown Facility
Rochester, New York, 14618, United States
Unknown Facility
Elizabeth City, North Carolina, 27909, United States
Unknown Facility
Oklahoma City, Oklahoma, 73120, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Portland, Oregon, 97213, United States
Unknown Facility
Philadelphia, Pennsylvania, 19115, United States
Unknown Facility
Simpsonville, South Carolina, 29681, United States
Unknown Facility
Chattanooga, Tennessee, 37421, United States
Unknown Facility
Austin, Texas, 78750, United States
Unknown Facility
Braunfels, Texas, 78130, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Burke, Virginia, 22015, United States
Unknown Facility
Richmond, Virginia, 23225, United States
Unknown Facility
Morgantown, West Virginia, 26505, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Hanrahan, M.D.
Sumitomo Pharma America, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 2, 2008
Study Start
September 1, 2005
Primary Completion
January 1, 2006
Study Completion
March 1, 2006
Last Updated
February 22, 2012
Record last verified: 2012-02