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

Sponsor:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00583986

Purpose

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

Condition	Intervention	Phase
Asthma Chronic Obstructive Pulmonary Disease COPD	Drug: Levalbuterol HFA MDI with top mounted actuation indicator	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:

The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	150
Study Start Date:	September 2005
Study Completion Date:	March 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Levalbuterol HFA MDI with top mounted actuation indicator	Drug: Levalbuterol HFA MDI with top mounted actuation indicator Levalbuterol HFA MDA with top mounted actuation indicator

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.

Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583986

Hide Study Locations

Locations

United States, California

Viejo, California, United States, 92691

Orange County, California, United States, 92868

San Jose, California, United States, 95128

Riverside, California, United States, 92506

Mesa, California, United States, 92626

Walnut Creek, California, United States, 94596

Encinatas, California, United States, 92024

San Diego, California, United States, 92120

Huntington Beach, California, United States, 92647
United States, Florida

Tamarac, Florida, United States, 33321
United States, Massachusetts

Dartmouth, Massachusetts, United States, 02747
United States, New York

Rochester, New York, United States, 14618

Commack, New York, United States, 11725
United States, North Carolina

Elizabeth City, North Carolina, United States, 27909
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73120
United States, Oregon

Medford, Oregon, United States, 97504

Portland, Oregon, United States, 97213
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19115
United States, South Carolina

Simpsonville, South Carolina, United States, 29681
United States, Tennessee

Chattanooga, Tennessee, United States, 37421
United States, Texas

San Antonio, Texas, United States, 78229

Braunfels, Texas, United States, 78130

Austin, Texas, United States, 78750
United States, Virginia

Richmond, Virginia, United States, 23225

Burke, Virginia, United States, 22015
United States, West Virginia

Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Sepracor, Inc.

Investigators

Study Chair:

John Hanrahan, M.D.

Sepracor, Inc.

More Information

Additional Information:

Patient's Instructions for Use This link exits the ClinicalTrials.gov site

Results

No publications provided

Responsible Party:	Sepracor Inc. ( Xopenex Medical Director )
Study ID Numbers:	051-357
Study First Received:	December 21, 2007
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00583986 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

top mounted
actuation indicator
Asthma
COPD
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Adrenergic Agents
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses

Immune System Diseases
Adrenergic beta-Agonists
Respiration Disorders
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 27, 2009