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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
For inclusion in the study subjects should fulfil the following criteria:
Exclusion Criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Clearwater | Florida | 37765 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11520721 | Background | 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. | |
| 23619732 | Background |
| Label | URL |
|---|---|
| Clinical COPD Questionnaire website | View source |
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Subjects who entered the study already on a stable dose of Symbicort were enrolled and randomized at Visit 1 followed by a 26-week treatment period. Subjects who converted to Symbicort were enrolled at Visit 1 and entered a 25-day run-in period after which they were randomized at Visit 2, followed by a 26-week treatment period.
Subjects with chronic obstructive pulmonary disease (COPD) were recruited into 8 study sites in the United States from August 2016 to October 2017. The study evaluated the impact of medication reminders on adherence to Symbicort pressurized metered dose inhaler (pMDI) using a BreatheMate bluetooth device that monitored daily Symbicort inhaler use.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance. |
| FG001 | Intervention Group | All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline population consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study (FAS).
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. | Posted | Mean | Standard Deviation | Adherent sets of puffs / day | From baseline to end of treatment (EOT), (6 months). |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CONTROL GROUP | All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | AstraZeneca | +1 302 885 1180 | ClinicalTrialTransparency@astrazeneca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 3, 2016 | Oct 5, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2017 | Oct 5, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| 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. |
|
| 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. | 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. | 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. | 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. | From baseline to EOT (6 months). |
| Tampa |
| Florida |
| 33603 |
| United States |
| Research Site | Marlton | New Jersey | 08053 | United States |
| Research Site | Brooklyn | New York | 11229 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Downingtown | Pennsylvania | 19335 | United States |
| Research Site | Philadelphia | Pennsylvania | 19140 | United States |
| Research Site | Spartanburg | South Carolina | 29303 | United States |
| 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. |
| 25058738 | 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. |
| 25899176 | 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. |
| 12354338 | 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. |
| 24979972 | Background | Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep. 2013 May 8;61(4):1-117. |
| 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. |
| 22521808 | 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. |
| 9847260 | 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. |
| 12773199 | 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. |
| 8635378 | 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. |
| Background | Clinical COPD Questionnaire website. http://ccq.nl/?page_id=15. Accessed January 15, 2016. |
| D589CL00003\_CSP\_redacted | View source |
| D589CL00003\_SAP\_redacted | View source |
| Device Technology Issue |
|
| Death |
|
| Did Not Start Treatment with Symbicort |
|
| Lost to Follow-up |
|
| Lost Device |
|
| Adverse Event |
|
| BG001 | Intervention Group | All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
All subjects took Symbicort pMDI budesonide/formoterol, 160/4.5 micrograms (mcg) x 2 actuations twice daily (BID), for oral inhalation from day 1 (baseline) of the treatment phase.
Subjects randomized to the control group received Symbicort pMDI and a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the control group did not receive any reminders to take their Symbicort or any feedback regarding medication compliance.
| OG001 | Intervention Group | All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application. |
|
|
|
| Secondary | 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. | The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with CCQ results available for analysis are presented. | Posted | Mean | Standard Deviation | Units on the CCQ scale | From baseline to EOT (6 months). |
|
|
|
| Secondary | 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. | The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with CCQ results available for analysis are presented. | Posted | Mean | Standard Deviation | Units on the CCQ scale. | From baseline to EOT (6 months). |
|
|
|
| Secondary | 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. | The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with data available for analysis are presented. | Posted | Mean | Standard Deviation | Adherent sets of puffs / day | From baseline to EOT (6 months). |
|
|
|
| Secondary | 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. | The FAS consists of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. | Posted | Mean | Standard Deviation | Days | From baseline to EOT (6 months). |
|
|
|
| Secondary | 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. | The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with data available for analysis are presented. | Posted | Mean | Standard Deviation | Number of Refills | From baseline to EOT (6 months). |
|
|
|
| 0 |
| 70 |
| 5 |
| 70 |
| 18 |
| 70 |
| EG001 | INTERVENTION GROUP | All subjects took Symbicort pMDI, budesonide/formoterol, 160/4.5 mcg x 2 actuations BID, for oral inhalation from day 1 (baseline) of the treatment phase. Subjects randomized to the intervention group received Symbicort pMDI, a BreatheMate bluetooth monitoring device that monitored daily Symbicort inhaler use, as well as a study-supplied cellular phone that paired with the BreatheMate device to transmit data regarding Symbicort usage. Subjects in the intervention group also received audio-visual daily reminders (beeps and flashes) to take their Symbicort on the BreatheMate Bluetooth monitoring device, and medication reminders from the cellular phone application. | 1 | 67 | 8 | 67 | 15 | 67 |
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Trichiasis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Bladder hypertrophy | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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The only disclosure restriction on the PI is that within 2 years of study completion, the sponsor must review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| CCQ Total Score: EOT |
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| CCQ Total Score: Change from baseline |
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| Symptom Score: Baseline |
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| Symptom Score: EOT |
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| Symptom Score: Change from baseline |
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| Functional State Score: Baseline |
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| Functional State Score: EOT |
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| Functional State Score: Change from baseline |
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| Mental State Score: Baseline |
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| Mental State Score: EOT |
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| Mental State Score: Change from baseline |
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| CCQ Total Score: Interval 3, Week 27 |
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| CCQ Symptom Score: Interval 1, Week 9 |
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| CCQ Symptom Score: Interval 2, Week 18 |
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| CCQ Symptom Score: Interval 3, Week 27 |
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| CCQ Functional State Score: Interval 1, Week 9 |
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| CCQ Functional State Score: Interval 2, Week 18 |
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| CCQ Functional State Score: Interval 3, Week 27 |
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| CCQ Mental State Score: Interval 1, Week 9 |
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| CCQ Mental State Score: Interval 2, Week 18 |
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| CCQ Mental State Score: Interval 3, Week 27 |
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| Interval 2 |
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| Interval 3 |
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