Chronic Obstructive Pulmonary Disease (COPDPhase 4NCT02864342

Adherence Study in COPD Patients

A Phase 4 study testing Arm 1: BreatheMate device with application and Arm 2: BreatheMate device without application in people with Chronic Obstructive Pulmonary Disease (COPD, run by AstraZeneca at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 40 to 130 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD
What is being tested?: Arm 1: BreatheMate device with application and Arm 2: BreatheMate device without application
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 138 participants
Where: 8 sitesUnited States
Study dates: 12 Aug 2016to 31 Oct 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 12Show fewer

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Research Site
Brooklyn, New York, 11229
Research Site
Charlotte, North Carolina, 28207
Research Site
Clearwater, Florida, 37765
Research Site
Downingtown, Pennsylvania, 19335
Research Site
Marlton, New Jersey, 08053
Research Site
Philadelphia, Pennsylvania, 19140
Research Site
Spartanburg, South Carolina, 29303
Research Site
Tampa, Florida, 33603

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Chronic Obstructive Pulmonary Disease (COPD
Being tested: Arm 1: BreatheMate device with application, Arm 2: BreatheMate device without application
Keywords: chronic obstructive pulmonary disease, COPD, Respiratory, adherence, medication reminders
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arm 1: BreatheMate device with applicationDevice
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.
Arm 2: BreatheMate device without applicationDevice
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.

Study groups in NCT02864342
Study group	Role	What they receive
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 Receives: 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. Receives: Device: Arm 2: BreatheMate device without application

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
The CCQ is a 10-item measure of a subject's COPD symptoms, divided into 3 domains (Symptoms: Items 1, 2, 5 and 6; Functional State: Items 7, 8, 9, and 10; and Mental State: Items 3 and 4). Individual items within the CCQ were equally weighted. The total score was calculated by adding the scores of the 10 items and dividing that number by 10 (=number of items). In addition, individual domain scores were calculated. The total CCQ score and each of the 3 domain scores range from 0 (very good health status) to 6 (extremely poor health status). CCQ data was collected for all subjects at baseline and EOT visits. The mean CCQ total and domain scores at both baseline and 26 weeks (EOT) are presented along with the mean change from baseline at EOT or week 26. A positive change indicates worsening symptoms and a higher value is indicative of a poorer health status.
Measured: From baseline to EOT (6 months).
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
The CCQ is a 10-item measure of a subject's COPD symptoms, divided into 3 domains (Symptoms: Items 1, 2, 5 and 6; Functional State: Items 7, 8, 9, and 10; and Mental State: Items 3 and 4). Individual items within the CCQ were equally weighted. The total score was calculated by adding the scores of the 10 items and dividing that number by 10 (=number of items). Individual domain scores were also calculated. The total CCQ score and each of the 3 domain scores range from 0 (very good health status) to 6 (extremely poor health status). Subjects in the intervention group took the CCQ weekly throughout the study. The 26-week treatment period was broken down into 3, 2-month intervals: Interval 1: from study day 1 to study day 63 (inclusive), Interval 2: study day 64 to study day 126 (inclusive), Interval 3: study day 127 to EOT (inclusive). The last week of each 2-month interval was used to represent that interval and results are presented for the total CCQ score and the 3 domain scores.
Measured: From baseline to EOT (6 months).
Mean Number of Adherent Sets of Puffs Per Day for Each 2-Month Study Interval.
The mean number of adherent sets of Symbicort puffs per day was calculated for each subject, for each of the 3, 2-month study intervals. Interval 1: from study day 1 to study day 63 (inclusive); Interval 2: study day 64 to study day 126 (inclusive); Interval 3: study day 127 to EOT (inclusive). A set is 2 puffs taken on the same calendar day, with the 2 puffs taken within 60 minutes of each other. The mean number of sets of Symbicort puffs per day was determined only for the days during device time on study for each subject.
Measured: From baseline to EOT (6 months).
Mean Number of Adherent Days Over the 26-Week Study Period.
The total number of adherent days was defined as the number of treatment days a subject took 2 sets of 2 puffs of Symbicort and the inhalations in a puff set were within 60 minutes of each other. 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. The total number of adherent days for each subject was counted over the 26 week treatment period and the mean number of adherent days per group is presented.
Measured: From baseline to EOT (6 months).
Mean Number of Symbicort Prescription Refills at Pharmacy Over the 26-Week Study Period.
The total number of Symbicort prescriptions filled at a pharmacy during the 26-week treatment period was counted per subject. The mean number of Symbicort 30-day prescription refills per subject was then calculated and presented per group.
Measured: From baseline to EOT (6 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 201631 Oct 2017

First posted12 Aug 2016 (estimated)
Study start12 Aug 2016
Primary completion31 Oct 2017
Study completion31 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPDStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02864342
Sponsor's protocol ID: D589CL00003
Status last verified: Nov 2018
First submitted: 26 Jul 2016
Last updated: 20 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 11520721
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.
PubMed 23619732
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.
PubMed 25058738
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.
PubMed 25899176
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.
PubMed 12354338
Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep. 2013 May 8;61(4):1-117.
PubMed 24979972
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.
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.
PubMed 22521808
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.
PubMed 9847260
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.
PubMed 12773199
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.
PubMed 8635378
Clinical COPD Questionnaire website. http://ccq.nl/?page_id=15. Accessed January 15, 2016.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Study to Assess the Impact of Symbicort® pMDI Medication Reminders on Adherence in COPD Patients
ClinicalTrials.gov ID: NCT02864342
Acronym / sponsor ID: D589CL00003
Conditions: Chronic Obstructive Pulmonary Disease (COPD
Keywords: chronic obstructive pulmonary disease, COPD, Respiratory, adherence, medication reminders
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Quintiles, Inc.
Study start: 12 Aug 2016 (actual)
Primary completion: 31 Oct 2017 (actual)
Study completion: 31 Oct 2017 (actual)
First posted: 12 Aug 2016 (estimated)
Results: Posted 20 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BreatheMate device and application	Active comparator	Device: Arm 1: BreatheMate device with applicationBreatheMate 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
BreatheMate device without application	Placebo comparator	Device: Arm 2: BreatheMate device without applicationBreatheMate Bluetooth device that attaches to Symbicort pressurized Metered Dose Inhaler (pMDI) and cell phone without any reminders or alerts.

Who may qualify

Ages: 40 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arm 1: BreatheMate device with applicationThe 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.	Device	BreatheMate device and application
Arm 2: BreatheMate device without applicationThe 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.	Device	BreatheMate device without application

Primary outcome

Mean Number of Adherent Sets of Symbicort Puffs Per Day Over the 26-Week Study Period
Time frame: From baseline to end of treatment (EOT), (6 months).
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.

5 secondary outcomes

Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.
Time frame: From baseline to EOT (6 months).
Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.
Time frame: From baseline to EOT (6 months).
Mean Number of Adherent Sets of Puffs Per Day for Each 2-Month Study Interval.
Time frame: From baseline to EOT (6 months).
Mean Number of Adherent Days Over the 26-Week Study Period.
Time frame: From baseline to EOT (6 months).
Mean Number of Symbicort Prescription Refills at Pharmacy Over the 26-Week Study Period.
Time frame: From baseline to EOT (6 months).

Results and safety

Results posted to the registry on 20 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	70	55
Intervention Group	68	49

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

Time frame: From baseline to end of treatment (EOT), (6 months).. Mean (Standard Deviation). Unit: Adherent sets of puffs / day

Measure	Control Group n = 70	Intervention Group n = 67
Value	1.3 (0.51)	1.6 (0.39)

Control Group vs Intervention Group: p <0.001, Satterthwaite t-test

Population analysed: The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed at the informed consent visit (Visit 1), at study day 90 and at the last follow-up telephone contact 30-days after the EOT visit on day 180 (approximately 7 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CONTROL GROUP	5 of 70 (7.1%)	18 of 70 (25.7%)	0 of 70
INTERVENTION GROUP	8 of 67 (11.9%)	15 of 67 (22.4%)	1 of 67

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11520721Feenstra 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.
Background: PubMed 23619732Ford 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.
Background: PubMed 25058738Ford 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.
Background: PubMed 25899176Kern 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.
Background: PubMed 12354338Mannino 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.
Background: PubMed 24979972Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep. 2013 May 8;61(4):1-117.
BackgroundNational 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: PubMed 22521808Simoni-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.
Background: PubMed 9847260van 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.
Background: PubMed 12773199van 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.
Background: PubMed 8635378Simmons 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.
BackgroundClinical COPD Questionnaire website. http://ccq.nl/?page_id=15. Accessed January 15, 2016.
Clinical COPD Questionnaire websiteLink provided by the sponsor.
D589CL00003\_CSP\_redactedLink provided by the sponsor.
D589CL00003\_SAP\_redactedLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of Adherent Sets of Symbicort Puffs Per Day Over the 26-Week Study Period (time frame: From baseline to end of treatment (EOT), (6 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864342, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018; AzTrials last refreshed its copy on 27 Oct 2026.