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:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00583986
First received: December 21, 2007
Last updated: February 21, 2012
Last verified: February 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 26 Study Locations
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014