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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Chronic Bronchitis

Intervention: Albuterol (Drug)

Phase: N/A

Status: Completed

Sponsored by: Teva Branded Pharmaceutical Products, R&D Inc.

Official(s) and/or principal investigator(s):
Clinical Project Leader, Study Director, Affiliation: Teva Respiratory R&D

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: The number of times the counter advanced but the inhaler did not actuate

Secondary outcome: The number of times the inhaler actuated but the counter did not advance.

Eligibility

Minimum age: 4 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Additional Information

Starting date: March 2011
Last updated: June 21, 2012

Page last updated: August 23, 2015

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