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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583986
• Other study ID #: 051-357
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2007
• Last updated: February 21, 2012
• Start date: September 2005
• Est. completion date: March 2006

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Patient's Instructions for Use