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A Randomized Clinical Study to Assess the Impact of Symbicort® pMDI Medication Reminders on Adherence in COPD Patients
A randomized clinical study to assess the impact of Symbicort® pMDI medication reminders on adherence in COPD patients
Chronic obstructive pulmonary disease (COPD) is a common disease with substantial associated morbidity and mortality. COPD is the third leading cause of death in the US and claimed 133,965 US lives in 2009. In 2011 12.7 million US adults were estimated to have COPD. However, approximately 24 million US adults have evidence of impaired lung function, indicating an under diagnosis of COPD. COPD also has a potentially harmful economic impact. In 2010, COPD resulted in over 10 million office visits, nearly 1.5 million emergency department visits, 700,000 hospitalizations, and 133,575 deaths in the US. In 2010, US total medical treatment costs attributed solely to COPD (i.e., excluding comorbidities) were estimated to be $32.1 billion with an additional $3.9 billion in COPD costs resulting from worker absenteeism. Even in industrialized countries such as the US, where anti-smoking initiatives have been relatively successful, the legacy of past smoking behavior in aging populations ensures that the COPD burden will unavoidably continue to climb over the next 20 to 30 years. Adherence rates for inhaled combination therapy is poor (average 3.9 refills per year). COPD patients with lower adherence tend to have higher overall healthcare costs, as demonstrated in a 24 month study of 33,816 patients in the US, which found: Patients continuing therapy had lower costs of care by $3764 compared with patients who had ceased to take their maintenance therapy. COPD patients with higher adherence to prescribed regimens experienced fewer hospitalizations and lower Medicare costs (-$2185) than those who exhibited lower adherence behaviors. Given the poor adherence with inhaled combination therapy seen in patients with COPD, and associated morbidity/mortality and economic costs, the present study is being conducted to see if medication reminders can be used to improve adherence in this population.
Age
40 - 130 years
Sex
ALL
Healthy Volunteers
No
Research Site
Clearwater, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Marlton, New Jersey, United States
Research Site
Brooklyn, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Downingtown, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Spartanburg, South Carolina, United States
Start Date
August 12, 2016
Primary Completion Date
October 31, 2017
Completion Date
October 31, 2017
Last Updated
November 20, 2018
138
ACTUAL participants
Arm 1: BreatheMate device with application
DEVICE
Arm 2: BreatheMate device without application
DEVICE
Lead Sponsor
AstraZeneca
Collaborators
NCT07477600
NCT07382258
NCT07195838
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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