A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)

June 21, 2012 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter

This study is evaluating the effectiveness of a dose counter for an inhaler device used to deliver medication to people diagnosed with asthma or COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States
        • Teva Clinical Study Site
    • California
      • Mission Viejo, California, United States
        • Teva Clinical Study Site 10100
      • Orange, California, United States
        • Teva Clinical Study Site 10093
      • San Diego, California, United States
        • Teva Clinical Study Site 10089
    • Colorado
      • Wheat Ridge, Colorado, United States
        • Teva Clinical Study Site 10098
    • Florida
      • Miami, Florida, United States
        • Teva Clinical Study Site
      • Ormond Beach, Florida, United States
        • Teva Clinical Study Site 10082
      • Tamarac, Florida, United States
        • Teva Clinical Study Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Teva Clinical Study Site 10090
    • Kansas
      • Overland Park, Kansas, United States
        • Teva Clinical Study Site 10097
      • Wichita, Kansas, United States
        • Teva Clinical Study Site 10087
    • Massachusetts
      • Fall River, Massachusetts, United States
        • Teva Clinical Study Site
      • North Dartmouth, Massachusetts, United States
        • Teva Clinical Study Site 10094
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Teva Clinical Study Site 10086
    • North Carolina
      • High Point, North Carolina, United States
        • Teva Clinical Study Site 10083
      • Raleigh, North Carolina, United States
        • Teva Clinical Study Site 10092
    • Ohio
      • Canton, Ohio, United States
        • Teva Clinical Study Site 10085
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Teva Clinical Study Site 10080
    • Oregon
      • Eugene, Oregon, United States
        • Teva Clinical Study Site 10088
      • Portland, Oregon, United States
        • Teva Clinical Study Site 10095
    • South Carolina
      • Greenville, South Carolina, United States
        • Teva Clinical Study Site 10081
      • Spartanburg, South Carolina, United States
        • Teva Clinical Study Site 10084
    • Texas
      • Dallas, Texas, United States
        • Teva Clinical Study Site
      • New Braunfels, Texas, United States
        • Teva Clinical Study Site 10091
    • Washington
      • Seattle, Washington, United States
        • Teva Clinical Study Site 10099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People diagnosed with asthma or Chronic Obstructive Pulmonary Disease (also known as COPD, emphysema or chronic bronchitis)

Description

Inclusion Criteria:

  • Written informed consent/assent
  • General good health
  • Asthma or COPD
  • Capable of understanding the requirements, risks, and benefits of study participation.
  • Able to demonstrate proper metered-dose inhaler use and technique.
  • Other inclusion criteria apply

Exclusion Criteria:

  • History of life-threatening asthma or COPD that is defined for this protocol as an asthma or COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
  • Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of Screening Visit.
  • Is being treated with a long-acting β2-agonist alone.
  • Is currently being treated with Ventolin HFA.
  • Any asthma or COPD exacerbation requiring oral corticosteroids within 2 months of Screening Visit. A subject must not have had any hospitalization for asthma or COPD within 4 months prior to Screening Visit.
  • Historical or current evidence of a clinically significant non-asthmatic acute or chronic condition.
  • Uncontrolled hypertension
  • History of any adverse reaction to any component of the HFA-MDI formulation.
  • Participation in any investigational drug study within the 30 days preceding the Screening Visit.
  • Other exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Albuterol MDI
All participants in this study will receive an albuterol MDI inhaler.
Drug: Albuterol
Albuterol MDI with integrated dose counter. Each participant will use 2 oral inhalations of 90 micrograms each of albuterol twice a day for the length of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of times the counter advanced but the inhaler did not actuate
Time Frame: Days 1 through 46
MDI actuates but the counter display does not advance.
Days 1 through 46

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of times the inhaler actuated but the counter did not advance.
Time Frame: Days 1 through 46
Counter advances but the MDI does not actuate.
Days 1 through 46

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (ESTIMATE)

February 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABM-AS-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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