Asthma, Chronic Obstructive Pulmonary Disease, COPD
Conditions
Keywords
top mounted, actuation indicator, Asthma, COPD, Chronic Obstructive Pulmonary Disease
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.
Interventions
DRUGLevalbuterol HFA MDI with top mounted actuation indicator
Levalbuterol HFA MDA with top mounted actuation indicator
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI. | 10 weeks |
Countries
United States
Outcome results
None listed