Adherence Study in COPD Patients

NCT02864342 | Completed Phase 4 Results

• 1 other identifier: D589CL00003
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 8

Brief Summary

A randomized clinical study to assess the impact of Symbicort® pMDI medication reminders on adherence in COPD patients

Conditions

Chronic Obstructive Pulmonary Disease (COPD

Keywords

chronic obstructive pulmonary disease; COPD; Respiratory; adherence; medication reminders

Outcome Measures

Primary Outcomes (1)

• Mean Number of Adherent Sets of Symbicort Puffs Per Day Over the 26-Week Study Period

  The mean number of adherent sets of Symbicort puffs per day for each group, over an average of 26 weeks was calculated. An adherent set of puffs was defined as exactly 2 sets of 2 Symbicort puffs per day. The 2 puffs that constitute a set must have been taken within 60 minutes of each other. A mean of 2.00 sets would be equal to 100% adherence (2 sets of 2 puffs). Subjects who did not take exactly 2 sets of 2 puffs on any given day throughout their device time on study were considered non-adherent for that day.

  From baseline to end of treatment (EOT), (6 months).

Secondary Outcomes (5)

• Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.

  From baseline to EOT (6 months).

• Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.

  From baseline to EOT (6 months).

• Mean Number of Adherent Sets of Puffs Per Day for Each 2-Month Study Interval.

  From baseline to EOT (6 months).

• Mean Number of Adherent Days Over the 26-Week Study Period.

  From baseline to EOT (6 months).

• Mean Number of Symbicort Prescription Refills at Pharmacy Over the 26-Week Study Period.

  From baseline to EOT (6 months).

Study Arms (2)

BreatheMate device and application

ACTIVE COMPARATOR

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

BreatheMate device without application

PLACEBO COMPARATOR

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

Interventions

Arm 1: BreatheMate device with application DEVICE

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.

BreatheMate device and application

Arm 2: BreatheMate device without application DEVICE

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.

BreatheMate device without application

Eligibility Criteria

• Age: 40 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead
• Quintiles, Inc.: collaborator

Study Sites (8)

Research Site

Clearwater, Florida, 37765, United States

Location

Research Site

Tampa, Florida, 33603, United States

Location

Research Site

Marlton, New Jersey, 08053, United States

Location

Research Site

Brooklyn, New York, 11229, United States

Location

Research Site

Charlotte, North Carolina, 28207, United States

Location

Research Site

Downingtown, Pennsylvania, 19335, United States

Location

Research Site

Philadelphia, Pennsylvania, 19140, United States

Location

Research Site

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (12)

• Feenstra TL, van Genugten ML, Hoogenveen RT, Wouters EF, Rutten-van Molken MP. The impact of aging and smoking on the future burden of chronic obstructive pulmonary disease: a model analysis in the Netherlands. Am J Respir Crit Care Med. 2001 Aug 15;164(4):590-6. doi: 10.1164/ajrccm.164.4.2003167.

  PMID: 11520721 BACKGROUND

• Ford ES, Croft JB, Mannino DM, Wheaton AG, Zhang X, Giles WH. COPD surveillance--United States, 1999-2011. Chest. 2013 Jul;144(1):284-305. doi: 10.1378/chest.13-0809.

  PMID: 23619732 BACKGROUND

• Ford ES, Murphy LB, Khavjou O, Giles WH, Holt JB, Croft JB. Total and state-specific medical and absenteeism costs of COPD among adults aged >/= 18 years in the United States for 2010 and projections through 2020. Chest. 2015 Jan;147(1):31-45. doi: 10.1378/chest.14-0972.

  PMID: 25058738 BACKGROUND

• Kern DM, Davis J, Williams SA, Tunceli O, Wu B, Hollis S, Strange C, Trudo F. Comparative effectiveness of budesonide/formoterol combination and fluticasone/salmeterol combination among chronic obstructive pulmonary disease patients new to controller treatment: a US administrative claims database study. Respir Res. 2015 Apr 23;16(1):52. doi: 10.1186/s12931-015-0210-x.

  PMID: 25899176 BACKGROUND

• Mannino DM, Homa DM, Akinbami LJ, Ford ES, Redd SC. Chronic obstructive pulmonary disease surveillance--United States, 1971-2000. Respir Care. 2002 Oct;47(10):1184-99.

  PMID: 12354338 BACKGROUND

• Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep. 2013 May 8;61(4):1-117.

  PMID: 24979972 BACKGROUND

• 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.

  BACKGROUND

• Simoni-Wastila L, Wei YJ, Qian J, Zuckerman IH, Stuart B, Shaffer T, Dalal AA, Bryant-Comstock L. Association of chronic obstructive pulmonary disease maintenance medication adherence with all-cause hospitalization and spending in a Medicare population. Am J Geriatr Pharmacother. 2012 Jun;10(3):201-10. doi: 10.1016/j.amjopharm.2012.04.002. Epub 2012 Apr 21.

  PMID: 22521808 BACKGROUND

• van den Boom G, van Schayck CP, van Mollen MP, Tirimanna PR, den Otter JJ, van Grunsven PM, Buitendijk MJ, van Herwaarden CL, van Weel C. Active detection of chronic obstructive pulmonary disease and asthma in the general population. Results and economic consequences of the DIMCA program. Am J Respir Crit Care Med. 1998 Dec;158(6):1730-8. doi: 10.1164/ajrccm.158.6.9709003.

  PMID: 9847260 BACKGROUND

• 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 Apr 28;1:13. doi: 10.1186/1477-7525-1-13.

  PMID: 12773199 BACKGROUND

• Simmons MS, Nides MA, Rand CS, Wise RA, Tashkin DP. Trends in compliance with bronchodilator inhaler use between follow-up visits in a clinical trial. Chest. 1996 Apr;109(4):963-8. doi: 10.1378/chest.109.4.963.

  PMID: 8635378 BACKGROUND

• Clinical COPD Questionnaire website. http://ccq.nl/?page_id=15. Accessed January 15, 2016.

  BACKGROUND

Related Links

• Clinical COPD Questionnaire website
• D589CL00003\_CSP\_redacted
• D589CL00003\_SAP\_redacted

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Enrolment was terminated early due to technical issues with the technologies provided at some clinical sites. The resulting impact on statistical power due to the reduced sample size likely imposes limits on the interpretability of this study.

Results Point of Contact

• Title: Medical Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

+1 302 885 1180

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 12, 2016
• Study Start: August 12, 2016
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: November 20, 2018
• Results First Posted: November 20, 2018

Record last verified: 2018-11

Locations

US (8)