Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD

Completed · Phase 3

Conditions studied: Asthma, Chronic Obstructive Pulmonary Disease, COPD

In brief

This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.

Key facts

Study ID

NCT00583986

Run by

Sumitomo Pharma America, Inc.

People needed

150

Starts

2005-09-01

Expected to finish

2006-03-01

Last updated by the study team

2012-02-22

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Encinatas, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Mesa, California, United States
• Study site — Orange County, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — San Jose, California, United States
• Study site — Viejo, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Tamarac, Florida, United States
• Study site — Russells Mills, Massachusetts, United States
• Study site — Commack, New York, United States
• Study site — Rochester, New York, United States
• Study site — Elizabeth City, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Medford, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Simpsonville, South Carolina, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Braunfels, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Burke, Virginia, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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