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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Albuterol MDI

All participants in this study will receive an albuterol MDI inhaler.

Albuterol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No