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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma; Chronic Obstructive Pulmonary Disease; COPD

Intervention: Levalbuterol HFA MDI with top mounted actuation indicator (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sunovion

Official(s) and/or principal investigator(s):
John Hanrahan, M.D., Study Chair, Affiliation: Sunovion

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.

Clinical Details

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

Primary outcome: The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.

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

Minimum age: 4 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Encinatas, California 92024, United States

Huntington Beach, California 92647, United States

Mesa, California 92626, United States

Orange County, California 92868, United States

Riverside, California 92506, United States

San Diego, California 92120, United States

San Jose, California 95128, United States

Viejo, California 92691, United States

Walnut Creek, California 94596, United States

Tamarac, Florida 33321, United States

Dartmouth, Massachusetts 02747, United States

Commack, New York 11725, United States

Rochester, New York 14618, United States

Elizabeth City, North Carolina 27909, United States

Oklahoma City, Oklahoma 73120, United States

Medford, Oregon 97504, United States

Portland, Oregon 97213, United States

Philadelphia, Pennsylvania 19115, United States

Simpsonville, South Carolina 29681, United States

Chattanooga, Tennessee 37421, United States

Austin, Texas 78750, United States

Braunfels, Texas 78130, United States

San Antonio, Texas 78229, United States

Burke, Virginia 22015, United States

Richmond, Virginia 23225, United States

Morgantown, West Virginia 26505, United States

Additional Information

Patient's Instructions for Use

Starting date: September 2005
Last updated: February 21, 2012

Page last updated: August 23, 2015

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