Clinical trial NCT01302587: A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
Official title: A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Emphysema
Chronic Bronchitis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 306
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People diagnosed with asthma or Chronic Obstructive Pulmonary Disease (also known as COPD, emphysema or chronic bronchitis)

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.


Eligibility 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.

Primary outcomes:
measure: The number of times the counter advanced but the inhaler did not actuate
timeFrame: Days 1 through 46
Secondary outcomes:
measure: The number of times the inhaler actuated but the counter did not advance.
timeFrame: Days 1 through 46
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Teva Clinical Study Site
state: Arizona
city: Mission Viejo
country: United States
facility: Teva Clinical Study Site 10100
state: California
city: Orange
country: United States
facility: Teva Clinical Study Site 10093
state: California
city: San Diego
country: United States
facility: Teva Clinical Study Site 10089
state: California
city: Wheat Ridge
country: United States
facility: Teva Clinical Study Site 10098
state: Colorado
city: Miami
country: United States
facility: Teva Clinical Study Site
state: Florida
city: Ormond Beach
country: United States
facility: Teva Clinical Study Site 10082
state: Florida
city: Tamarac
country: United States
facility: Teva Clinical Study Site
state: Florida
city: Indianapolis
country: United States
facility: Teva Clinical Study Site 10090
state: Indiana
city: Overland Park
country: United States
facility: Teva Clinical Study Site 10097
state: Kansas
city: Wichita
country: United States
facility: Teva Clinical Study Site 10087
state: Kansas
city: Fall River
country: United States
facility: Teva Clinical Study Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: Teva Clinical Study Site 10094
state: Massachusetts
city: Minneapolis
country: United States
facility: Teva Clinical Study Site 10086
state: Minnesota
city: High Point
country: United States
facility: Teva Clinical Study Site 10083
state: North Carolina
city: Raleigh
country: United States
facility: Teva Clinical Study Site 10092
state: North Carolina
city: Canton
country: United States
facility: Teva Clinical Study Site 10085
state: Ohio
city: Tulsa
country: United States
facility: Teva Clinical Study Site 10080
state: Oklahoma
city: Eugene
country: United States
facility: Teva Clinical Study Site 10088
state: Oregon
city: Portland
country: United States
facility: Teva Clinical Study Site 10095
state: Oregon
city: Greenville
country: United States
facility: Teva Clinical Study Site 10081
state: South Carolina
city: Spartanburg
country: United States
facility: Teva Clinical Study Site 10084
state: South Carolina
city: Dallas
country: United States
facility: Teva Clinical Study Site
state: Texas
city: New Braunfels
country: United States
facility: Teva Clinical Study Site 10091
state: Texas
city: Seattle
country: United States
facility: Teva Clinical Study Site 10099
state: Washington
Study officials:
affiliation: Teva Respiratory R&D
name: Clinical Project Leader
role: STUDY_DIRECTOR
References:
citation: 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.