A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter
1 other identifier
observational
306
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Shorter than P25 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
February 24, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 22, 2012
June 1, 2012
3 months
February 16, 2011
June 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The number of times the inhaler actuated but the counter did not advance.
Days 1 through 46
Study Arms (1)
Albuterol MDI
All participants in this study will receive an albuterol MDI inhaler.
Interventions
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.
Eligibility Criteria
People diagnosed with asthma or Chronic Obstructive Pulmonary Disease (also known as COPD, emphysema or chronic bronchitis)
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
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
Related Publications (1)
Given J, Taveras H, Iverson H, Lepore M. Prospective, open-label assessment of albuterol sulfate hydrofluoroalkane metered-dose inhaler with new integrated dose counter. Allergy Asthma Proc. 2013 Jan-Feb;34(1):42-51. doi: 10.2500/aap.2012.33.3647. Epub 2012 Dec 20.
PMID: 23265285DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Project Leader
Teva Respiratory R&D
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2011
First Posted
February 24, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 22, 2012
Record last verified: 2012-06