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

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01302587
• Collaborator: (none)
• Enrollment: 306
• Locations: 25
• Duration (Months): 3
• Patients Per Site: 12.2
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma; Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Chronic Bronchitis	Drug: Albuterol

Study Design

• Study Type: Observational
• Actual Enrollment: 306 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Albuterol MDI All participants in this study will receive an albuterol MDI inhaler.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teva Clinical Study Site	Glendale	Arizona	United States
2	Teva Clinical Study Site 10100	Mission Viejo	California	United States
3	Teva Clinical Study Site 10093	Orange	California	United States
4	Teva Clinical Study Site 10089	San Diego	California	United States
5	Teva Clinical Study Site 10098	Wheat Ridge	Colorado	United States
6	Teva Clinical Study Site	Miami	Florida	United States
7	Teva Clinical Study Site 10082	Ormond Beach	Florida	United States
8	Teva Clinical Study Site	Tamarac	Florida	United States
9	Teva Clinical Study Site 10090	Indianapolis	Indiana	United States
10	Teva Clinical Study Site 10097	Overland Park	Kansas	United States
11	Teva Clinical Study Site 10087	Wichita	Kansas	United States
12	Teva Clinical Study Site	Fall River	Massachusetts	United States
13	Teva Clinical Study Site 10094	North Dartmouth	Massachusetts	United States
14	Teva Clinical Study Site 10086	Minneapolis	Minnesota	United States
15	Teva Clinical Study Site 10083	High Point	North Carolina	United States
16	Teva Clinical Study Site 10092	Raleigh	North Carolina	United States
17	Teva Clinical Study Site 10085	Canton	Ohio	United States
18	Teva Clinical Study Site 10080	Tulsa	Oklahoma	United States
19	Teva Clinical Study Site 10088	Eugene	Oregon	United States
20	Teva Clinical Study Site 10095	Portland	Oregon	United States
21	Teva Clinical Study Site 10081	Greenville	South Carolina	United States
22	Teva Clinical Study Site 10084	Spartanburg	South Carolina	United States
23	Teva Clinical Study Site	Dallas	Texas	United States
24	Teva Clinical Study Site 10091	New Braunfels	Texas	United States
25	Teva Clinical Study Site 10099	Seattle	Washington	United States

Sponsors and Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

• Study Director: Clinical Project Leader, Teva Respiratory R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT01302587
• Other Study ID Numbers: ABM-AS-307
• First Posted: Feb 24, 2011
• Last Update Posted: Jun 22, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema; Albuterol

Study Results

No Results Posted as of Jun 22, 2012