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

Sumitomo Pharma

Status and phase

Completed

Phase 3

Conditions

Asthma

Chronic Obstructive Pulmonary Disease

COPD

Treatments

Drug: Levalbuterol HFA MDI with top mounted actuation indicator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00583986

051-357

Details and patient eligibility

About

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

Full 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.

Enrollment

150 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

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.