A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
- Conditions
- AsthmaChronic BronchitisChronic Obstructive Pulmonary Disease (COPD)Emphysema
- Interventions
- Registration Number
- NCT01302587
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Albuterol MDI Albuterol All participants in this study will receive an albuterol MDI inhaler.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (21)
Teva Clinical Study Site 10099
🇺🇸Seattle, Washington, 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 10084
🇺🇸Spartanburg, South Carolina, United States
Teva Clinical Study Site 10100
🇺🇸Mission Viejo, California, United States
Teva Clinical Study Site
🇺🇸Dallas, Texas, 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 10082
🇺🇸Ormond Beach, Florida, United States
Teva Clinical Study Site 10086
🇺🇸Minneapolis, Minnesota, United States
Teva Clinical Study Site 10094
🇺🇸North Dartmouth, Massachusetts, 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 10088
🇺🇸Eugene, Oregon, United States
Teva Clinical Study Site 10080
🇺🇸Tulsa, Oklahoma, 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 10091
🇺🇸New Braunfels, Texas, United States