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

Study Overview
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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.

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

Conditions
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Asthma, Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Chronic Bronchitis

Intervention / Treatment
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* Drug: Albuterol


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Albuterol MDI<br>All participants in this study will receive an albuterol MDI inhaler. | Drug: Albuterol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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