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

Completed

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

In brief

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.

Key facts

Study ID

NCT01302587

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

306

Starts

2011-03-01

Expected to finish

2011-06-01

Last updated by the study team

2012-06-22

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Teva Clinical Study Site — Glendale, Arizona, United States
• Teva Clinical Study Site 10100 — Mission Viejo, California, United States
• Teva Clinical Study Site 10093 — Orange, California, United States
• Teva Clinical Study Site 10089 — San Diego, California, United States
• Teva Clinical Study Site 10098 — Wheat Ridge, Colorado, United States
• Teva Clinical Study Site — Miami, Florida, United States
• Teva Clinical Study Site 10082 — Ormond Beach, Florida, United States
• Teva Clinical Study Site — Tamarac, Florida, United States
• Teva Clinical Study Site 10090 — Indianapolis, Indiana, United States
• Teva Clinical Study Site 10097 — Overland Park, Kansas, United States
• Teva Clinical Study Site 10087 — Wichita, Kansas, United States
• Teva Clinical Study Site — Fall River, Massachusetts, United States
• Teva Clinical Study Site 10094 — North Dartmouth, Massachusetts, United States
• Teva Clinical Study Site 10086 — Minneapolis, Minnesota, United States
• Teva Clinical Study Site 10083 — High Point, North Carolina, United States
• Teva Clinical Study Site 10092 — Raleigh, North Carolina, United States
• Teva Clinical Study Site 10085 — Canton, Ohio, United States
• Teva Clinical Study Site 10080 — Tulsa, Oklahoma, United States
• Teva Clinical Study Site 10088 — Eugene, Oregon, United States
• Teva Clinical Study Site 10095 — Portland, Oregon, United States
• Teva Clinical Study Site 10081 — Greenville, South Carolina, United States
• Teva Clinical Study Site 10084 — Spartanburg, South Carolina, United States
• Teva Clinical Study Site — Dallas, Texas, United States
• Teva Clinical Study Site 10091 — New Braunfels, Texas, United States
• Teva Clinical Study Site 10099 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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