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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Albuterol

Criteria

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.