Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
Information source: Sepracor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Chronic Obstructive Pulmonary Disease; COPD
Intervention: Levalbuterol HFA MDI with top mounted actuation indicator (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sepracor, Inc. Official(s) and/or principal investigator(s):
John Hanrahan, M.D., Study Chair, Affiliation: Sepracor, Inc.
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.
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.
Eligibility
Minimum age: 4 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Viejo, California 92691, United States
Orange County, California 92868, United States
San Jose, California 95128, United States
Walnut Creek, California 94596, United States
Mesa, California 92626, United States
Riverside, California 92506, United States
Encinatas, California 92024, United States
San Diego, California 92120, United States
Huntington Beach, California 92647, United States
Tamarac, Florida 33321, United States
Dartmouth, Massachusetts 02747, United States
Rochester, New York 14618, United States
Commack, New York 11725, United States
Elizabeth City, North Carolina 27909, United States
Oklahoma City, Oklahoma 73120, United States
Medford, Oregon 97504, United States
Portland, Oregon 97213, United States
Philadelphia, Pennsylvania 19115, United States
Simpsonville, South Carolina 29681, United States
Chattanooga, Tennessee 37421, United States
San Antonio, Texas 78229, United States
Braunfels, Texas 78130, United States
Austin, Texas 78750, United States
Richmond, Virginia 23225, United States
Burke, Virginia 22015, United States
Morgantown, West Virginia 26505, United States
Additional Information
Patient's Instructions for Use Results
Starting date: September 2005
Ending date: March 2006
Last updated: June 6, 2008
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