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”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2006

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.

Intervention(s) in this Clinical Trial

• Drug: Levalbuterol HFA MDI with top mounted actuation indicator
  • Levalbuterol HFA MDA with top mounted actuation indicator

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Levalbuterol HFA MDI with top mounted actuation indicator

Primary Measures

• The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.
  • Time Frame: 10 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sepracor, Inc.

Overall Clinical Trial Officials and Contacts

John Hanrahan, M.D. Study Chair Sepracor, Inc.  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00583986

Study ID Number: 051-357

ClinicalTrials.gov Identifier: NCT00583986

Health Authority: United States: Food and Drug Administration

Patient's Instructions for Use

Results