A Phase 4 interventional study of RELVAR/BREO and Salbutamol in Asthma, sponsored by GlaxoSmithKline. Completed at 66 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-12.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
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Among 261 studies in Asthma by GlaxoSmithKline — 7 open to participants now, 12 under way, 7 of them phase 3. Asthma · GlaxoSmithKline.
Among the 261 studies in Asthma by GlaxoSmithKline, this one is the 51st largest by enrollment of the 237 interventional ones that give a count, is one of 9 that started in 2018, is one of 53 in phase 4, and was the 228th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →7 of the 261 studies in Asthma by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Argentina, Canada and 1 more country
Ages 18+
GlaxoSmithKline · Sites in United States
Ages 12–80
GlaxoSmithKline · Sites in United States, Japan
Ages 12–80
GlaxoSmithKline · Sites in United States
Ages 6–11
GlaxoSmithKline · Sites in United States, United Kingdom
Ages 12+
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
261 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 63 · Phase 2 59 · Phase 3 61 · Phase 4 53
First in 1999; this study’s year is marked. 9 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 437 is above the median of 79 across 3,344 interventional studies indexed under Asthma.
Median enrollment 100 across the 237 interventional studies, 512 across the 24 observational. Of the 239 that completed or were terminated, 131 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
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.
5 of the studies in Asthma by GlaxoSmithKline that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07645248Phase 3GlaxoSmithKlineA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a) | 2026-12-28 |
| NCT05757102Phase 3GlaxoSmithKlineA Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma | 2027-01-26 |
| NCT07671001Phase 3GlaxoSmithKlineA Study of Depemokimab in Participants of 6 to 11 Years of Age | 2027-03-01 |
| NCT07712393GlaxoSmithKlineA Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283 | 2027-04-13 |
| NCT06433921GlaxoSmithKlineA Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive | 2027-04-16 |
Add all 5 to your calendar (.ics) → With an account.
Among the 261 studies in Asthma by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the rescue medication metered dose inhaler (MDI). The data from both sensors will be fed back to the subject via an application (app) on smart phone and will be reviewed by the subject's health care professional (HCP) via an online dashboard. The sensors, app, dashboard and systems to provide data comprise the CIS. This study will be the first to evaluate the effect of CIS on adherence to maintenance therapy in subjects with uncontrolled asthma. This is an open-label, randomized, parallel group study in asthmatic subjects currently on a fixed dose inhaled corticosteroid (ICS)/long-acting beta 2 agonist (LABA) maintenance therapy. Eligible subjects will receive RELVAR®/BREO® maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers during the run-in period, which may last for up to 3 months. Eligible subjects will then be randomized into five treatment arms depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol MDI, is fed back to the subject or subject and HCP, or not at all. The treatment period for the study is approximately 6 months and there will be a follow-up period one week post last visit. The total duration of a subject in the study will be approximately 9 months. RELVAR, BREO and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
Inclusion Criteria:
Inclusion criteria for randomization:
Exclusion Criteria:
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensor attached to RELVAR/BREO ELLIPTA will be fed back to the subject via an app on smart phone and to the subject's HCP via an online dashboard.
Drug: RELVAR/BREO · Drug: Salbutamol · Device: Smart phone app · Device: HCP Dashboard · Device: Sensors
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensor attached to RELVAR/BREO ELLIPTA will be fed back to the subject via an app on smart phone.
Drug: RELVAR/BREO · Drug: Salbutamol · Device: Smart phone app · Device: Sensors
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensors attached to RELVAR/BREO ELLIPTA and salbutamol MDI will be fed back to both subject and HCP. The data will be fed back to the subject through an app and to HCP through an online dashboard.
Drug: RELVAR/BREO · Drug: Salbutamol · Device: Smart phone app · Device: HCP Dashboard · Device: Sensors
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensors attached to RELVAR/BREO ELLIPTA and salbutamol MDI will be fed back to subject through an app.
Drug: RELVAR/BREO · Drug: Salbutamol · Device: Smart phone app · Device: Sensors
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Subjects will be provided with a home hub through which their data will be uploaded during the study but the subjects and their HCP will not be able to view the data.
Drug: RELVAR/BREO · Drug: Salbutamol · Device: Sensors
RELVAR/BREO will be available at doses of 100/25 micrograms (µg) and 200/25 µg to be administered via ELLIPTA DPI. Subjects will be administered one inhalation of RELVAR/BREO once daily.
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.
Subjects will be required to download an app associated with sensor on their smartphone. The sensors attached to the inhalers will be connected to the smartphone via Bluetooth.
The information from sensors will be reviewed by the HCP via an online dashboard.
Clip-on sensors will be fitted to electronically record the actuation data.
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; ("Cohort 1: Data on Maintenance Use Supplied to Participant and HCP" and"Cohort 5: no Data Supplied to Participant or HCP")
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 anti-meridiem (a.m.) each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Analysis was carried out by Analysis of Covariance (ANCOVA) model. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The daily adherence to ELLIPTA maintenance therapy when both the participant and the HCP were supplied with data from the maintenance sensor (Cohort 1) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
Time frame: Month 4 to Month 6
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The effect on daily adherence to maintenance therapy when maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
Time frame: Month 4 to Month 6
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 3 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
Time frame: Month 1 to Month 3
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 6 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
Time frame: Month 1 to Month 6
Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor
Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Percentage of rescue free days were determined by the rescue sensor records of date, time and number of inhaler actuations. Least Square mean percentage of rescue free days between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
Time frame: Month 4 to Month 6
Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor
Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Total rescue use was determined by the rescue sensor records of date, time and number of inhaler actuations. The mean number of doses of rescue medicines between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
Time frame: Month 4 to Month 6
Change From Baseline in Asthma Control Test (ACT) Total Score
The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline and Month 6
Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6
Percentage of participants attaining asthma control was defined as participants with an ACT total score \>=20 at Month 6. The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Percentage of participants who attained asthma control at Month 6 is presented.
Time frame: Month 6
Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6
The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants with an increase from Baseline \>=3 in ACT total score at Month 6 is presented.
Time frame: Baseline and Month 6
Percentage of Participants Who Have Either an ACT Total Score of >=20 and/or an Increase From Baseline >=3 in ACT Total Score at Month 6
The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants who had either an ACT total score of \>=20 and/or an increase from Baseline \>=3 in ACT total score at Month 6 is presented.
Time frame: Baseline and Month 6
This was an open-label, randomized, multi-center, parallel group study to evaluate the effect of the connected inhaler system (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic participants (Par) with poor control.
| Milestone | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Started | 87 | 88 | 88 | 88 | 86 |
| Completed | 82 | 81 | 77 | 78 | 81 |
| Not completed | 5 | 7 | 11 | 10 | 5 |
| Withdrew: Physician decision | 0 | 1 | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 3 | 3 | 5 | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 | 4 | 3 | 1 |
| Withdrew: Protocol violation | 1 | 0 | 1 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 2 | 1 |
| Withdrew: Adverse event | 1 | 1 | 1 | 2 | 0 |
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 anti-meridiem (a.m.) each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Analysis was carried out by Analysis of Covariance (ANCOVA) model. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The daily adherence to ELLIPTA maintenance therapy when both the participant and the HCP were supplied with data from the maintenance sensor (Cohort 1) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
| Percentage of ELLIPTA doses | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; ("Cohort 1: Data on Maintenance Use Supplied to Participant and HCP" and"Cohort 5: no Data Supplied to Participant or HCP") | 80.9 ± 3.19 | 69.0 ± 3.19 |
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The effect on daily adherence to maintenance therapy when maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
| Percentage of ELLIPTA doses | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor | 77.2 ± 3.04 | 78.3 ± 3.11 | 77.1 ± 3.25 | 69.0 ± 3.19 |
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 3 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
| Percentage of ELLIPTA doses | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor | 85.7 ± 2.82 | 84.2 ± 2.66 | 82.0 ± 2.74 | 79.2 ± 2.78 | 76.4 ± 2.82 |
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 6 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
| Percentage of ELLIPTA doses | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor | 81.5 ± 3.07 | 78.8 ± 2.90 | 77.7 ± 2.99 | 75.2 ± 3.03 | 71.8 ± 3.07 |
Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Percentage of rescue free days were determined by the rescue sensor records of date, time and number of inhaler actuations. Least Square mean percentage of rescue free days between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
| Percentage of rescue free days | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | 81.1 ± 2.82 | 81.2 ± 2.66 | 85.6 ± 2.76 | 83.7 ± 2.80 | 76.4 ± 2.82 |
Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Total rescue use was determined by the rescue sensor records of date, time and number of inhaler actuations. The mean number of doses of rescue medicines between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
| Doses of rescue medication | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | 55.3 ± 107.73 | 40.6 ± 91.53 | 29.5 ± 54.41 | 27.0 ± 45.27 | 55.8 ± 158.49 |
The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Scores on a Scale | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Change From Baseline in Asthma Control Test (ACT) Total Score | 3.4 ± 0.40 | 4.3 ± 0.40 | 4.7 ± 0.41 | 4.2 ± 0.41 | 3.9 ± 0.40 |
Percentage of participants attaining asthma control was defined as participants with an ACT total score \>=20 at Month 6. The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Percentage of participants who attained asthma control at Month 6 is presented.
| Percentage of participants | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6 | 52 | 66 | 55 | 53 | 62 |
The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants with an increase from Baseline \>=3 in ACT total score at Month 6 is presented.
| Percentage of participants | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6 | 61 | 69 | 65 | 63 | 64 |
The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants who had either an ACT total score of \>=20 and/or an increase from Baseline \>=3 in ACT total score at Month 6 is presented.
| Percentage of participants | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Percentage of Participants Who Have Either an ACT Total Score of >=20 and/or an Increase From Baseline >=3 in ACT Total Score at Month 6 | 66 | 75 | 65 | 67 | 70 |
Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 6 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Data on Maintenance Use Supplied to Par and HCP | 0/87 (0%) | 2/87 (2.3%) | 4/87 (4.6%) |
| Cohort 2: Data on Maintenance Use Supplied to Par | 0/88 (0%) | 1/88 (1.1%) | 1/88 (1.1%) |
| Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | 0/88 (0%) | 2/88 (2.3%) | 1/88 (1.1%) |
| Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | 0/88 (0%) | 1/88 (1.1%) | 1/88 (1.1%) |
| Cohort 5: No Data Supplied to Par or HCP | 0/86 (0%) | 4/86 (4.7%) | 2/86 (2.3%) |
| Event | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 1/87 | 0/88 | 0/88 | 0/88 | 1/86 |
| CellulitisInfections and infestations | 0/87 | 0/88 | 0/88 | 0/88 | 1/86 |
| Upper gastrointestinal hemorrhageGastrointestinal disorders | 0/87 | 0/88 | 0/88 | 0/88 | 1/86 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/87 | 0/88 | 0/88 | 0/88 | 1/86 |
| Obstructive pancreatitisGastrointestinal disorders | 1/87 | 0/88 | 0/88 | 0/88 | 0/86 |
| Cholecystitis acuteHepatobiliary disorders | 1/87 | 0/88 | 0/88 | 0/88 | 0/86 |
| HyponatremiaMetabolism and nutrition disorders | 1/87 | 0/88 | 0/88 | 0/88 | 0/86 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/87 | 0/88 | 0/88 | 0/88 | 0/86 |
| Non-cardiac chest painGeneral disorders | 0/87 | 0/88 | 1/88 | 0/88 | 0/86 |
| Fibula fractureInjury, poisoning and procedural complications | 0/87 | 0/88 | 0/88 | 1/88 | 0/86 |
| Event | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP |
|---|---|---|---|---|---|
| Oral candidiasisInfections and infestations | 2/87 | 0/88 | 0/88 | 0/88 | 0/86 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/87 | 0/88 | 0/88 | 0/88 | 1/86 |
| NauseaGastrointestinal disorders | 0/87 | 1/88 | 0/88 | 0/88 | 1/86 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/87 | 0/88 | 0/88 | 1/88 | 1/86 |
| FatigueGeneral disorders | 0/87 | 0/88 | 0/88 | 0/88 | 1/86 |
| Oesophageal candidiasisInfections and infestations | 1/87 | 0/88 | 0/88 | 0/88 | 0/86 |
| DysphoniaRespiratory, thoracic and mediastinal disorders | 1/87 | 1/88 | 0/88 | 0/88 | 0/86 |
| Oral fungal infectionInfections and infestations | 0/87 | 1/88 | 0/88 | 0/88 | 0/86 |
| Upper respiratory tract infectionInfections and infestations | 0/87 | 0/88 | 1/88 | 0/88 | 0/86 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/87 | 0/88 | 0/88 | 1/88 | 0/86 |
| Age, Continuous(Years) | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP | Total |
|---|---|---|---|---|---|---|
| Mean | 46.7 ± 15.79 | 47.0 ± 14.70 | 47.8 ± 15.28 | 47.8 ± 13.23 | 47.2 ± 15.91 | 47.3 ± 14.95 |
| Sex: Female, Male(Participants) | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP | Total |
|---|---|---|---|---|---|---|
| Female | 64 | 54 | 59 | 60 | 47 | 284 |
| Male | 23 | 34 | 29 | 28 | 39 | 153 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Cohort 2: Data on Maintenance Use Supplied to Par | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Cohort 5: No Data Supplied to Par or HCP | Total |
|---|---|---|---|---|---|---|
| American Indian (AI) or Alaska native (AN) | 1 | 0 | 0 | 0 | 2 | 3 |
| Asian-Central/South Asian Heritage | 1 | 3 | 1 | 2 | 1 | 8 |
| Asian-East Asian Heritage | 1 | 0 | 0 | 0 | 1 | 2 |
| Asian-South East (SE) Asian Heritage (AH) | 2 | 2 | 3 | 2 | 3 | 12 |
| Black or African American | 10 | 3 | 8 | 9 | 4 | 34 |
| Native Hawaiian or other Pacific Islander | 0 | 1 | 0 | 0 | 0 | 1 |
| White-Arabic/North African heritage | 0 | 0 | 0 | 1 | 1 | 2 |
| White-White/Caucasian/European Heritage (EH) | 72 | 76 | 76 | 74 | 73 | 371 |
| AI or AN and Black or African American | 0 | 2 | 0 | 0 | 0 | 2 |
| AI or AN and White- White/Caucasian/EH | 0 | 1 | 0 | 0 | 0 | 1 |
| Asian-SE AH and White- White/Caucasian/EH | 0 | 0 | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Jan 2018 to primary completion in Jan 2019, 11 months.
Results were first posted in Feb 2020, 1 year after primary completion.
Of 66 industry-sponsored phase 4 interventional studies under Asthma, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 33. This study's 11 months is below that.
Counting every sponsor, half of 156 studies reached it within 24 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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