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

Asthma Clinical Trial

Official title:

A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302587
• Other study ID #: ABM-AS-307
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: June 21, 2012
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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 ß2-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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease (COPD)
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Albuterol
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The number of times the inhaler actuated but the counter did not advance.	Counter advances but the MDI does not actuate.	Days 1 through 46	No