Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
This study has been completed.
Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00583986
First received: December 21, 2007
Last updated: February 21, 2012
Last verified: February 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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:
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
U.S. FDA Resources
Further study details as provided by Sunovion:
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 |
|---|---|
|
Experimental: 1
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
Other Name: Xopenex HFA®
|
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| 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
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Hide Study LocationsLocations
| United States, California | |
| Encinatas, California, United States, 92024 | |
| Huntington Beach, California, United States, 92647 | |
| Mesa, California, United States, 92626 | |
| Orange County, California, United States, 92868 | |
| Riverside, California, United States, 92506 | |
| San Diego, California, United States, 92120 | |
| San Jose, California, United States, 95128 | |
| Viejo, California, United States, 92691 | |
| Walnut Creek, California, United States, 94596 | |
| United States, Florida | |
| Tamarac, Florida, United States, 33321 | |
| United States, Massachusetts | |
| Dartmouth, Massachusetts, United States, 02747 | |
| United States, New York | |
| Commack, New York, United States, 11725 | |
| Rochester, New York, United States, 14618 | |
| 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 | |
| Austin, Texas, United States, 78750 | |
| Braunfels, Texas, United States, 78130 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Burke, Virginia, United States, 22015 | |
| Richmond, Virginia, United States, 23225 | |
| United States, West Virginia | |
| Morgantown, West Virginia, United States, 26505 | |
Sponsors and Collaborators
Sunovion
Investigators
| Study Chair: | John Hanrahan, M.D. | Sunovion |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00583986 History of Changes |
| Other Study ID Numbers: | 051-357 |
| Study First Received: | December 21, 2007 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sunovion:
|
top mounted actuation indicator Asthma COPD Chronic Obstructive Pulmonary Disease |
Additional relevant MeSH terms:
|
Asthma Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Tocolytic Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 23, 2013