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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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