Asthma, Chronic Bronchitis, Chronic Obstructive Pulmonary Disease (COPD), Emphysema
Conditions
Brief summary
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.
Interventions
DRUGAlbuterol
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.
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of times the counter advanced but the inhaler did not actuate | Days 1 through 46 | MDI actuates but the counter display does not advance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of times the inhaler actuated but the counter did not advance. | Days 1 through 46 | Counter advances but the MDI does not actuate. |
Countries
United States
Outcome results
None listed