We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "astrazeneca" "breathemate"
Previous Study | Return to List | Next Study

Adherence Study in COPD Patients

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02864342
First Posted: August 12, 2016
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
A randomized clinical study to assess the impact of Symbicort® pMDI medication reminders on adherence in COPD patients

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD Device: Arm 1: BreatheMate device with application Device: Arm 2: BreatheMate device without application Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Randomized Clinical Study to Assess the Impact of Symbicort® pMDI Medication Reminders on Adherence in COPD Patients

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adherence measured as mean number of sets of puffs/day for the entire 6 month study period [ Time Frame: For the entire 6 month study period ]
    Example: Mean of 2.00 would be equal to 100% adherence (2 sets of 2 puffs). To constitute as a set, 2 puffs must be taken within 60 minutes.


Secondary Outcome Measures:
  • Mean Clinical COPD Questionnaire (CCQ) symptom score (total, symptom, mental, and function score) in the control vs. intervention group [ Time Frame: At week 1 and week 26, and change over the 6 month period. ]
  • Mean total weekly CCQ scores [ Time Frame: every 2 months up to 24 weeks ]
  • Mean domain weekly CCQ scores [ Time Frame: every 2 months up to 24 weeks ]
  • Mean # of sets of puffs/day for each 2 month study interval [ Time Frame: every 2 months up to 24 weeks ]
  • Mean # of adherent days (2 sets of 2 puffs per day) per subject [ Time Frame: For the entire 6 month study period ]
  • Total number of adherent days (2 sets of 2 puffs per day) per subject. [ Time Frame: For the entire 6 month study period ]
  • Mean prescription refills at pharmacy [ Time Frame: For the entire 6 month study period ]

Enrollment: 138
Actual Study Start Date: August 12, 2016
Estimated Study Completion Date: November 22, 2017
Estimated Primary Completion Date: November 22, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BreatheMate device and application
BreatheMate Bluetooth device that attaches to Symbicort pressurized Metered Dose Inhaler (pMDI) and cell phone with application that sends medication and refill reminders and reminders to complete a COPD questionnaire
Device: Arm 1: BreatheMate device with application
The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. Subjects will receive audio-visual daily reminders (beeps and flashes) on the BreatheMate Bluetooth device. The bluetooth device transmits this data to a cellular phone that is provided to all subjects in the study. Subjects in the intervention group will also receive audio-visual alerts (beeps, flashes) from the bluetooth device to take their medication.
Placebo Comparator: BreatheMate device without application
BreatheMate Bluetooth device that attaches to Symbicort pressurized Metered Dose Inhaler (pMDI) and cell phone without any reminders or alerts.
Device: Arm 2: BreatheMate device without application

The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. The functionality of audio-visual daily reminders (beeps and flashes) is deactivated for this control group.

The BreatheMate service also includes a cellular phone that will display whether the Bluetooth monitoring device is paired and communicating with the cellular phone. The Bluetooth device will transmit data regarding medication usage to the cellular phone.


Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For inclusion in the study subjects should fulfil the following criteria:

  • Signed informed consent at Visit 1 prior to any study specific procedures
  • Outpatient adults 40 years and older
  • A diagnosis of COPD confirmed by a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) <0.70 at some point in the past 3 years.
  • Moderate to Very Severe COPD as defined by a post-bronchodilator FEV1 <80% of predicted on most recent spirometry.
  • Had been on an ICS/LABA combination therapy of a brand and dose approved forCOPD, for at least 3 months prior to screening.
  • Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year).
  • Willing to discontinue all medications containing both a LABA and an ICS and to begin Symbicort 160/4.5 μg, 2 inhalations bid.
  • Must be willing to make a return visit, and complete all study assessments for the duration of study.
  • Life expectancy >12 months.
  • Must be willing to comply with all study procedures including being able to remove and attach device to the inhaler.
  • Must be able and willing to read and write/respond using the electronic device provided.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • Previous randomization in the present study.
  • Patients who have been randomized in a clinical study and received an investigational product within 30 days of Visit 1 (participation is defined as the completion of a treatment related visit).
  • Current diagnosis of asthma.
  • Known history of drug or alcohol abuse which, in the opinion of the Investigator, may interfere with subject's ability to participate or comply with the study.
  • An acute exacerbation of COPD that required hospitalization or emergency room visit or treatment with systemic steroids and/or antibiotics during the 28 days before Visit 1. Patients who had a COPD exacerbation within 28 days of Visit 1 can be re-screened once. Re-screening can occur no earlier than 28 days from the last dose of systemic steroids and/or antibiotics and/or hospitalization, whichever is later.
  • Enrolled patients that have a COPD exacerbation during the run-in period, defined as worsening symptoms which in the judgment of the Investigator requires treatment with systemic steroids and/or antibiotics and/or hospitalization. Patients who had a COPD exacerbation during the run-in period can be re-screened once. Re-screening can occur no earlier than 28 days from the last dose of systemic steroid and/or antibiotics and/or hospitalization, whichever is later.
  • Any hospital admissions due to ischemic heart disease or heart failure within 3 months of study enrollment.
  • Any significant disease or disorder (e.g., gastrointestinal, liver, renal, neurologic, musculoskeletal, endocrine, metabolic, infectious, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study.
  • History of lung or upper airway cancer and any other malignancy not in remission for 5 years or more, except for patients who have had basal cell carcinoma, or in situ carcinoma of the cervix provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
  • Use or planned use of systemic corticosteroids as a maintenance treatment (defined as daily or every other day treatment for 21 or more days) for inflammatory or immunologic conditions unrelated to their COPD.
  • Planned hospitalization or surgical procedure requiring inpatient stay during the study.
  • Pregnancy, breast-feeding or planned pregnancy during the study; fertile women not using acceptable contraceptive measures, as judged by the Investigator. Female subjects who are not post-menopausal or surgically sterile must have a negative urine pregnancy test (urine dipstick test only) prior to randomization and must comply with contraceptive methods.
  • Any clinically relevant abnormal findings in physical examination or vital signs, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study.
  • Known or suspected hypersensitivity to the study therapy (Symbicort).
  • Patients who are unable or unwilling to use mobile communication devices, or patients who plan to be away from home for a significant part of the study without access to cellular connectivity are excluded because of the challenges of collecting data and providing information to these patients who are unable to use the service.
  • Patients with thoracic surgery within 6 months of Visit 1.
  • Patients who have received a lung transplant or are currently active on the lung transplant waiting list.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864342


Locations
United States, Florida
Research Site
Clearwater, Florida, United States, 37765
Research Site
Tampa, Florida, United States, 33603
United States, New Jersey
Research Site
Marlton, New Jersey, United States, 08053
United States, New York
Research Site
Brooklyn, New York, United States, 11229
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
Research Site
Downingtown, Pennsylvania, United States, 19335
Research Site
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Research Site
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
AstraZeneca
Quintiles, Inc.
  More Information

Additional Information:
Publications:
National Institutes of Health National Heart, Lung, and Blood Institute Fact Book Prevalence of Common Cardiovascular and Lung Diseases, U.S., 2007-2011. https://www nhlbi nih gov/about/documents/factbook/2012/chapter4 htm#4_5 ;2014.
van der Molen T, Willemse BW, Schokker S, ten Hacken, NH, Postma DS, Juniper EF. Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes 2003;1:13. DOI: 10.1186/1477-7525-1-13.
Clinical COPD Questionnaire website. http://ccq.nl/?page_id=15. Accessed January 15, 2016.

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02864342     History of Changes
Other Study ID Numbers: D589CL00003
First Submitted: July 26, 2016
First Posted: August 12, 2016
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by AstraZeneca:
chronic obstructive pulmonary disease
COPD
Respiratory
adherence
medication reminders

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents