An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by GlaxoSmithKline · Observational
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Among 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline — 7 open to participants now, 8 under way, 5 of them phase 3. Pulmonary Disease, Chronic Obstructive · GlaxoSmithKline.
Among the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline, this one is the 34th largest by enrollment of the 40 observational ones that give a count, is one of 12 that started in 2018, is one of 40 observational ones, and was the 243rd registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →7 of the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Argentina
Ages 40–80
GlaxoSmithKline · Sites in United States, Japan
Ages 40–80
GlaxoSmithKline · Sites in United Kingdom
Ages 18–55 · Healthy volunteers
GlaxoSmithKline · Sites in United States, Australia, Bulgaria and 10 more countries
Ages 40–75
GlaxoSmithKline · Sites in United States, Argentina, Australia and 13 more countries
Ages 40–80
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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276 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 47 · Phase 3 65 · Phase 4 38
First in 2000; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 194 is above the median of 159 across 1,498 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 101 across the 236 interventional studies, 1,248 across the 40 observational. Of the 264 that completed or were terminated, 141 (53%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
2 of the studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06154837GlaxoSmithKlineA Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease | 2026-12-16 |
| NCT07789899GlaxoSmithKlineA Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants | 2027-09-07 |
Add all 2 to your calendar (.ics) → With an account.
Among the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a pilot study that will evaluate the feasibility of collecting increasing amounts of clinical study data from subjects through sensor and web/app based methods and integrating it with data from their EHR to facilitate more efficient and meaningful research with acceptable quality. Approximately 100 subjects with asthma and 100 subjects with chronic obstructive pulmonary disease (COPD) will be enrolled in this prospective study. The subjects will be identified through integrated EHR records following which eligible subjects will receive study devices and training on proper use of the devices at Baseline visit. Data will be collected remotely from subject reports, devices and sensors over six months.
Two cohorts consisting of approximately 100 subjects each with COPD and asthma identified through EHR database analyses will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
cohort
Asthma cohort
Exclusion Criteria:
cohort
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 100 subjects with COPD identified through integrated EHR records will be enrolled.
Device: Mobile spirometer · Device: Device sensor · Drug: Salbutamol · Device: Activity monitor · Other: electronic diary card · Other: CAT
Approximately 100 subjects with asthma identified through integrated EHR records will be enrolled.
Device: Mobile spirometer · Device: Device sensor · Drug: Salbutamol · Device: Activity monitor · Other: ACT
Mobile spirometer will be used to measure FEV1 values weekly.
Sensors will be attached to rescue and maintenance inhalers to measure use of rescue medication and maintenance therapy.
Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.
Subjects will be required to wear activity monitors daily to record their physical activity.
Electronic diary card will be completed daily by subjects in COPD cohort.
Subjects will be required to complete CAT monthly.
Subjects will be required to complete ACT monthly.
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Participants were given a hand-held spirometer with instructions on its proper use. Baseline (Week 1) measurement was taken in clinic and the participants were instructed to perform home spirometry on a weekly basis for the remainder of the study. The spirometry use was linked to the Propeller Health application on the iPad, which provided visual cues for the spirometry and sent the data to the central database after completion of the session. Change from Baseline was calculated as the value at specified time point minus Baseline value. Change from Baseline in FEV1 at 4-weekly intervals is presented.
Time frame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
Median Number of Steps Per Day
The physical activity was captured using a waist-worn accelerometer. A valid day was defined as a day where the activity monitor detected that it was worn for at least 8 hours during that day. Data for three or more valid days were required to generate data for weekly step counts.
Time frame: Weeks 1, 5, 9, 13, 17, 21 and 25
Median Daily Activity Level Based on Vector Magnitude Counts.
The physical activity was captured using a waist-worn accelerometer. Vector magnitude in counts are accelerations in 3 dimensions that indicate activity. More counts is associated with more activity.
Time frame: Weeks 1, 5, 9, 13, 17, 21 and 25
Patient Reported Outcome (PRO) Active Total Score
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of PRO was used, and was offered via the participant's electronic PRO application every 28 days. This version of PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'amount' domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute \[VMU/min\] and steps per day). The 'difficulty' domain is covered by 10 items. Each domain score is based on the simple addition of items (scale ranging from 0 to 15 for amount domain and 0 to 40 for difficulty domain), and then scaled from 0 to 100. 'Total Score' is calculated as the sum of the two domains (amount and difficulty) divided by two, thus scored from 0 (worse) to 100 (much better).
Time frame: Weeks 2, 6, 10, 14, 18, 22 and 26
PROactive Amount Domain Score
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains (amount and difficulty). The amount domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute \[VMU/min\] and steps per day). Amount domain score is based on the simple addition of items (scale ranging from 0 to 15) and then scaled from 0 to 100.
Time frame: Weeks 2, 6, 10, 14, 18, 22 and 26
PROactive Difficulty Domain Score
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'difficulty' domain is covered by 10 items. The difficulty domain score is based on the simple addition of items (0 to 40), which is then scaled from 0 (worse) to 100 (much better).
Time frame: Weeks 2, 6, 10, 14, 18, 22 and 26
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
The E-RS: COPD scale is a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. The E-RS utilizes the 11 respiratory symptom items contained in the 14-item Exacerbations of Chronic pulmonary disease Tool (EXACT). For the COPD cohort specifically, the daily EXACT was offered each evening. The domains included: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range \[0-17\]), RS-cough and sputum (RS-CSP comprised of 3 items, score range \[0-11\]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range \[0-12\]). The total score was derived by summing the 11-item scores and ranged between 0-40 with higher values indicating severe respiratory symptoms. Scores for the week were summarized for each COPD participant where they completed the questionnaire on three or more days during the study week
Time frame: Weeks 1, 5, 9, 13, 17, 21 and 25
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only
EXACT is a 14-item diary that measures respiratory symptoms and function. The total score for EXACT ranges from 0-100, higher scores indicate more severe symptoms. EXACT events are considered worsening of symptom scores above the individual's Baseline value over multiple consecutive days.
Time frame: Up to 6 months
Number of Primary Care Visits for Asthma Conditions or COPD
The number of primary care visits (including ambulatory, home and phone) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization.
Time frame: Up to 6 months
Number of Secondary Care Visits for Asthma Conditions or COPD
The number of secondary care visits (that is, inpatient hospitalization and emergency department \[ED\]) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization
Time frame: Up to 6 months
Number of All Primary Care Visits
The number of all primary care visits (including ambulatory, home and phone) were summarized using data from EHR-based healthcare utilization
Time frame: Up to 6 months
Number of All Secondary Care Visits
The number of all secondary care visits (that is, inpatient hospitalization and ED) were summarized using data from EHR-based healthcare utilization
Time frame: Up to 6 months
Number of Participants With New Prescriptions
New treatments that were prescribed for respiratory-related conditions (Short-acting beta-agonists \[SABA\], Inhaled corticosteroid (ICS)/long-acting beta-agonist \[LABA\] combinations, Oral corticosteroids \[OCS\], Leukotriene modifiers \[LEUK\], ICS, Long-acting muscarinic antagonists \[LAMA\], SABA/short-acting muscarinic antagonist \[SAMA\] combinations, Anti-cholinergics \[a-CHOL\], LABA/LAMA, ICS/LABA/LAMA, Phosphodiesterase type 4 inhibitors \[PDE4\], Anti-immunoglobulin E \[a-IgE\], LABA, and Interleukin-5 inhibitors \[IL-5\]) were summarized using data from EHR-based healthcare utilization. Some participants may have received prescriptions in more than one medication category.
Time frame: Up to 6 months
Number of Days in Hospital for Asthma and COPD
The number of days for which the participant was hospitalized for asthma and COPD was summarized using data from EHR-based healthcare utilization
Time frame: Up to 6 months
Number of Participants Who Received Short-acting Beta-agonist Therapy
Participants who received SABA were summarized using data from EHR-based healthcare utilization.
Time frame: Up to 6 months
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment). Total score was calculated by summing the non-missing scores on the eight items and ranged from 0-40. Higher scores indicated greater disease impact. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value.
Time frame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale (1 to 5). Total score was calculated as the sum of scores from 5 questions and ranged from 5 to 25. Higher scores indicated better control of asthma. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value.
Time frame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
Median Rescue Medication Use
The use of rescue medication by participants were monitored by attaching a sensor to rescue inhaler.
Time frame: Weeks 1, 5, 9, 13, 17, 21, 25
Percentage of Participants With Maintenance Compliance
The use of maintenance therapy by participants were monitored by attaching a sensor to maintenance inhaler.
Time frame: Weeks 1, 5, 9, 13, 17, 21 and 25
Number of Participants Who Completed Exit Interview
An exit interview were conducted to obtain relevant feedback from participants regarding the study, study devices and electronic PRO platform. Exit surveys were triggered via the study-supplied iPad to each participant when they completed (or withdrew from) the study.
Time frame: Up to 6 Months
This was a prospective observational study that included two cohorts of participants identified through electronic health records (EHR) within the Geisinger Health System (GHS) database. The study was conducted at a single center in the United States.
| Milestone | Asthma Cohort | COPD Cohort |
|---|---|---|
| Started | 96 | 98 |
| Completed | 89 | 86 |
| Not completed | 7 | 12 |
| Withdrew: Withdrawal by subject | 3 | 6 |
| Withdrew: Lost to follow-up | 4 | 5 |
| Withdrew: Death | 0 | 1 |
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Participants were given a hand-held spirometer with instructions on its proper use. Baseline (Week 1) measurement was taken in clinic and the participants were instructed to perform home spirometry on a weekly basis for the remainder of the study. The spirometry use was linked to the Propeller Health application on the iPad, which provided visual cues for the spirometry and sent the data to the central database after completion of the session. Change from Baseline was calculated as the value at specified time point minus Baseline value. Change from Baseline in FEV1 at 4-weekly intervals is presented.
| Liter | Asthma Cohort | COPD Cohort |
|---|---|---|
| Week 5, n=61, 44 | -0.03 (-0.23 to 0.14) | 0.07 (-0.08 to 0.17) |
| Week 9, n=61,39 | -0.09 (-0.28 to 0.11) | -0.08 (-0.26 to 0.03) |
| Week 13, n=57, 40 | -0.06 (-0.22 to 0.14) | -0.10 (-0.22 to 0.06) |
| Week 17, n=54, 38 | -0.11 (-0.27 to 0.05) | -0.15 (-0.23 to 0.09) |
| Week 21, n=33, 28 | -0.07 (-0.22 to 0.08) | -0.19 (-0.51 to 0.00) |
| Week 25, n=26, 14 | -0.12 (-0.24 to 0.18) | -0.10 (-0.27 to 0.01) |
The physical activity was captured using a waist-worn accelerometer. A valid day was defined as a day where the activity monitor detected that it was worn for at least 8 hours during that day. Data for three or more valid days were required to generate data for weekly step counts.
| Steps per day | Asthma Cohort | COPD Cohort |
|---|---|---|
| Week 1, n=72, 68 | 3574 (2321 to 5584) | 2186 (1185 to 3320) |
| Week 5, n=53, 54 | 4547 (1956 to 6021) | 2446 (1281 to 3832) |
| Week 9, n=52,42 | 3270 (2161 to 6358) | 2312 (1335 to 3605) |
| Week 13, n=52, 42 | 3124 (1944 to 6425) | 2117 (1150 to 3390) |
| Week 17, n=47, 37 | 3962 (2160 to 6637) | 1583 (1148 to 2752) |
| Week 21, n=34, 31 | 3816 (1498 to 6547) | 1702 (912 to 3645) |
| Week 25, n=23, 20 | 3431 (1822 to 6501) | 2239 (1012 to 3139) |
The physical activity was captured using a waist-worn accelerometer. Vector magnitude in counts are accelerations in 3 dimensions that indicate activity. More counts is associated with more activity.
| Vector magnitude counts | Asthma Cohort | COPD Cohort |
|---|---|---|
| Week 1, n=72, 68 | 512 (407 to 658) | 378 (288 to 492) |
| Week 5, n=53, 54 | 475 (375 to 669) | 415 (302 to 578) |
| Week 9, n=52, 42 | 483 (348 to 629) | 389 (290 to 523) |
| Week 13, n=52, 42 | 469 (342 to 685) | 384 (268 to 541) |
| Week 17, n=47, 37 | 490 (375 to 670) | 342 (272 to 434) |
| Week 21, n=34, 31 | 525 (359 to 683) | 359 (242 to 608) |
| Week 25, n=23, 20 | 446 (343 to 661) | 412 (311 to 648) |
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of PRO was used, and was offered via the participant's electronic PRO application every 28 days. This version of PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'amount' domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute \[VMU/min\] and steps per day). The 'difficulty' domain is covered by 10 items. Each domain score is based on the simple addition of items (scale ranging from 0 to 15 for amount domain and 0 to 40 for difficulty domain), and then scaled from 0 to 100. 'Total Score' is calculated as the sum of the two domains (amount and difficulty) divided by two, thus scored from 0 (worse) to 100 (much better).
| Scores on a scale | Asthma Cohort | COPD Cohort |
|---|---|---|
| Week 2, n=54, 58 | 75 (66.5 to 78.5) | 60.3 (54.5 to 69) |
| Week 6, n=40, 52 | 75 (63.8 to 79.3) | 59 (55.3 to 66) |
| Week 10, n=35,36 | 73 (63.5 to 78.5) | 62.5 (53.5 to 69.5) |
| Week 14, n=36, 36 | 73.5 (65.5 to 79.3) | 58.5 (49.5 to 68.3) |
| Week 18, n=22, 22 | 75 (70 to 78.5) | 57.5 (52.5 to 61.5) |
| Week 22, n=21, 23 | 76.5 (67 to 81) | 56.5 (48.5 to 63.5) |
| Week 26, n=15, 12 | 75.5 (67 to 79) | 58 (56.3 to 67.8) |
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains (amount and difficulty). The amount domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute \[VMU/min\] and steps per day). Amount domain score is based on the simple addition of items (scale ranging from 0 to 15) and then scaled from 0 to 100.
| Scores on a scale | Asthma Cohort | COPD Cohort |
|---|---|---|
| Week 2, n=54, 58 | 61 (52 to 70) | 52 (48 to 57) |
| Week 6, n=40, 52 | 61 (52 to 65) | 54 (48 to 61) |
| Week 10, n=35,36 | 57 (52 to 65) | 57 (48 to 61) |
| Week 14, n=36, 36 | 59 (52 to 70) | 52 (44 to 63) |
| Week 18, n=22, 22 | 61 (57 to 75) | 52 (48 to 61) |
| Week 22, n=21, 23 | 61 (57 to 75) | 52 (39 to 61) |
| Week 26, n=15, 12 | 61 (57 to 70) | 54 (46 to 57) |
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'difficulty' domain is covered by 10 items. The difficulty domain score is based on the simple addition of items (0 to 40), which is then scaled from 0 (worse) to 100 (much better).
| Scores on a scale | Asthma Cohort | COPD Cohort |
|---|---|---|
| Week 2, n=68, 83 | 84.5 (73 to 94) | 66 (60 to 75) |
| Week 6, n=57, 77 | 86 (68 to 94) | 63 (56 to 77) |
| Week 10, n=54, 65 | 82 (72 to 92) | 65 (55 to 73) |
| Week 14, n=49, 56 | 83 (79 to 94) | 66 (56.5 to 83) |
| Week 18, n=39, 41 | 83 (75 to 92) | 61 (56 to 72) |
| Week 22, n=47, 50 | 86 (77 to 92) | 65.5 (53 to 70) |
| Week 26, n=28, 37 | 86 (78 to 94) | 65 (55 to 72) |
The E-RS: COPD scale is a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. The E-RS utilizes the 11 respiratory symptom items contained in the 14-item Exacerbations of Chronic pulmonary disease Tool (EXACT). For the COPD cohort specifically, the daily EXACT was offered each evening. The domains included: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range \[0-17\]), RS-cough and sputum (RS-CSP comprised of 3 items, score range \[0-11\]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range \[0-12\]). The total score was derived by summing the 11-item scores and ranged between 0-40 with higher values indicating severe respiratory symptoms. Scores for the week were summarized for each COPD participant where they completed the questionnaire on three or more days during the study week
| Scores on a scale | COPD Cohort |
|---|---|
| Week 1, n=72 | 16.5 (11.5 to 22.3) |
| Week 5, n=66 | 17.8 (12.0 to 23.5) |
| Week 9, n=60 | 17.1 (11.7 to 25.9) |
| Week 13, n=56 | 15.5 (12.4 to 23.4) |
| Week 17, n=52 | 15.8 (11.9 to 23.8) |
| Week 21, n=43 | 16.3 (11.5 to 23.0) |
| Week 25, n=41 | 15.3 (10.3 to 21.4) |
EXACT is a 14-item diary that measures respiratory symptoms and function. The total score for EXACT ranges from 0-100, higher scores indicate more severe symptoms. EXACT events are considered worsening of symptom scores above the individual's Baseline value over multiple consecutive days.
| Events per participant per year | COPD Cohort |
|---|---|
| Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only | 2.06 |
The number of primary care visits (including ambulatory, home and phone) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization.
| Visits | Asthma Cohort | COPD Cohort |
|---|---|---|
| Ambulatory | 23 | 79 |
| Home | 1 | 21 |
| Phone | 4 | 17 |
The number of secondary care visits (that is, inpatient hospitalization and emergency department \[ED\]) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization
| Visits | Asthma Cohort | COPD Cohort |
|---|---|---|
| Inpatient hospitalization | 0 | 0 |
| ED visits | 0 | 0 |
The number of all primary care visits (including ambulatory, home and phone) were summarized using data from EHR-based healthcare utilization
| Visits | Asthma Cohort | COPD Cohort |
|---|---|---|
| Ambulatory | 426 | 598 |
| Home | 7 | 55 |
| Phone | 87 | 116 |
The number of all secondary care visits (that is, inpatient hospitalization and ED) were summarized using data from EHR-based healthcare utilization
| Visits | Asthma Cohort | COPD Cohort |
|---|---|---|
| Inpatient hospitalization | 0 | 0 |
| ED visits | 0 | 0 |
New treatments that were prescribed for respiratory-related conditions (Short-acting beta-agonists \[SABA\], Inhaled corticosteroid (ICS)/long-acting beta-agonist \[LABA\] combinations, Oral corticosteroids \[OCS\], Leukotriene modifiers \[LEUK\], ICS, Long-acting muscarinic antagonists \[LAMA\], SABA/short-acting muscarinic antagonist \[SAMA\] combinations, Anti-cholinergics \[a-CHOL\], LABA/LAMA, ICS/LABA/LAMA, Phosphodiesterase type 4 inhibitors \[PDE4\], Anti-immunoglobulin E \[a-IgE\], LABA, and Interleukin-5 inhibitors \[IL-5\]) were summarized using data from EHR-based healthcare utilization. Some participants may have received prescriptions in more than one medication category.
| Participants | Asthma Cohort | COPD Cohort |
|---|---|---|
| SABA | 85 | 85 |
| ICS/LABA | 59 | 48 |
| OCS | 33 | 52 |
| LEUK | 37 | 14 |
| ICS | 30 | 15 |
| LAMA | 6 | 35 |
| SABA/SAMA | 9 | 22 |
| a-CHOL | 2 | 8 |
| LABA/LAMA | 0 | 9 |
| ICS/LABA/LAMA | 0 | 8 |
| PDE4 | 0 | 8 |
| a-IgE | 2 | 1 |
| LABA | 2 | 1 |
| IL-5 | 2 | 0 |
The number of days for which the participant was hospitalized for asthma and COPD was summarized using data from EHR-based healthcare utilization
| Days | Asthma Cohort | COPD Cohort |
|---|---|---|
| Number of Days in Hospital for Asthma and COPD | 0 | 0 |
Participants who received SABA were summarized using data from EHR-based healthcare utilization.
| Participants | Asthma Cohort | COPD Cohort |
|---|---|---|
| Number of Participants Who Received Short-acting Beta-agonist Therapy | 85 | 85 |
The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment). Total score was calculated by summing the non-missing scores on the eight items and ranged from 0-40. Higher scores indicated greater disease impact. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value.
| Scores on a scale | COPD Cohort |
|---|---|
| Week 5, n=71 | 0 (-4 to 4) |
| Week 9, n=67 | 0 (-3 to 3) |
| Week 13, n=60 | 1 (-3 to 3) |
| Week 17, n=56 | 0.5 (-3 to 4) |
| Week 21, n=50 | 1.5 (-2 to 4) |
| Week 25, n=48 | 0 (-3 to 4) |
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale (1 to 5). Total score was calculated as the sum of scores from 5 questions and ranged from 5 to 25. Higher scores indicated better control of asthma. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value.
| Scores on a scale | Asthma Cohort |
|---|---|
| Week 5, n=72 | 0 (-1 to 2) |
| Week 9, n=54 | 0 (-2 to 1) |
| Week 13, n=62 | 0 (-1 to 2) |
| Week 17, n=59 | 0 (-2 to 2) |
| Week 21, n=47 | 0 (-1 to 2) |
| Week 25, n=46 | 0 (-1 to 2) |
The use of rescue medication by participants were monitored by attaching a sensor to rescue inhaler.
| Occasions per day | Asthma Cohort | COPD Cohort |
|---|---|---|
| Week 1 | 0.3 (0.1 to 1.3) | 0.6 (0.1 to 1.7) |
| Week 5 | 0.2 (0 to 1) | 0.4 (0.1 to 1.3) |
| Week 9 | 0.1 (0 to 0.6) | 0.3 (0 to 0.9) |
| Week 13 | 0.1 (0 to 0.9) | 0.3 (0 to 0.9) |
| Week 17 | 0 (0 to 0.5) | 0.3 (0 to 0.9) |
| Week 21 | 0 (0 to 0.3) | 0.3 (0 to 0.7) |
| Week 25 | 0 (0 to 0.3) | 0.3 (0 to 1) |
The use of maintenance therapy by participants were monitored by attaching a sensor to maintenance inhaler.
| Percentage of Participants | Asthma Cohort | COPD Cohort |
|---|---|---|
| Week 1 | 68 | 64 |
| Week 5 | 59 | 56 |
| Week 9 | 54 | 54 |
| Week 13 | 52 | 50 |
| Week 17 | 48 | 48 |
| Week 21 | 48 | 49 |
| Week 25 | 46 | 48 |
An exit interview were conducted to obtain relevant feedback from participants regarding the study, study devices and electronic PRO platform. Exit surveys were triggered via the study-supplied iPad to each participant when they completed (or withdrew from) the study.
| Participants | Asthma Cohort | COPD Cohort |
|---|---|---|
| Number of Participants Who Completed Exit Interview | 96 | 80 |
Collected over Up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asthma Cohort | 0/96 (0%) | 0/96 (0%) | 0/96 (0%) |
| COPD Cohort | 1/98 (1%) | 0/98 (0%) | 0/98 (0%) |
| Age, Continuous(Years) | Asthma Cohort | COPD Cohort | Total |
|---|---|---|---|
| Median | 59 (44 to 67) | 64 (57 to 71) | 62 (52 to 69) |
| Sex: Female, Male(Participants) | Asthma Cohort | COPD Cohort | Total |
|---|---|---|---|
| Female | 63 | 66 | 129 |
| Male | 33 | 32 | 65 |
| Race/Ethnicity, Customized(Participants) | Asthma Cohort | COPD Cohort | Total |
|---|---|---|---|
| Caucasian | 93 | 94 | 187 |
| African-American | 1 | 4 | 5 |
| South East Asian | 1 | 0 | 1 |
| Unknown | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2018 to primary completion in Sep 2019, 14 months.
Results were first posted in Nov 2020, 1 year 1 month after primary completion.
Of 120 industry-sponsored observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's 14 months is below that.
Counting every sponsor, half of 587 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →