Clinical trial NCT00583986: Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
COPD
Keywords: top mounted
actuation indicator
Asthma
COPD
Chronic Obstructive Pulmonary Disease
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Encinatas
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Mesa
country: United States
state: California
city: Orange County
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Jose
country: United States
state: California
city: Viejo
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Tamarac
country: United States
state: Florida
city: Dartmouth
country: United States
state: Massachusetts
city: Commack
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Elizabeth City
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Simpsonville
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Braunfels
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Burke
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: John Hanrahan, M.D.
role: STUDY_CHAIR
References: