Asthma Clinical Trial
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
Verified date | February 2012 |
Source | Sunovion |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.
Status | Completed |
Enrollment | 150 |
Est. completion date | March 2006 |
Est. primary completion date | January 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sunovion |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI. | 10 weeks | Yes |
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