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

Phase 3

Completed

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease; COPD
• Interventions: Drug: Levalbuterol HFA MDI with top mounted actuation indicator

• Registration Number: NCT00583986
• Lead Sponsor: Sumitomo Pharma America, Inc.

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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-01
• Study Completion: 2006-03
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-02
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Levalbuterol HFA MDI with top mounted actuation indicator	Levalbuterol HFA MDI with top mounted actuation indicator

Primary Outcome Measures

Name	Time	Method
The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.	10 weeks