Trial · NCT03380429
A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
NCT03380429, Phase 4, Completed, GlaxoSmithKline; results first posted 2020-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects. Trials, record NCT03380429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03380429
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
- NCT number
- NCT03380429
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 437 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- RELVAR/BREO, Salbutamol, Smart phone app, HCP Dashboard, Sensors
- First posted
- 2017-12-21
- Last updated
- 2021-04-12
- Other registries' IDs
- eudract:2017-002266-45
- Results first posted
- 2020-02-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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") | Month 4 to Month 6 | 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. |
| Secondary | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor | Month 4 to Month 6 | 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. |
| Secondary | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor | Month 1 to Month 3 | 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. |
| Secondary | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor | Month 1 to Month 6 | 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. |
| Secondary | Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | Month 4 to Month 6 | 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. |
| Secondary | Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | Month 4 to Month 6 | 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. |
| Secondary | Change From Baseline in Asthma Control Test (ACT) Total Score | Baseline and 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). Change from Baseline was calculated as post-dose visit value minus the Baseline value. |
| Secondary | Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6 | 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. |
| Secondary | Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6 | Baseline and 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. |
| Secondary | 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 | Baseline and 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 andCohort 5: no Data Supplied to Participant or HCP) | Month 4 to Month 6 | Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error. Only those participants with adherence data observed/imputed at the specified time points were analyzed. | Percentage of ELLIPTA doses | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor | Month 4 to Month 6 | ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed. | Percentage of ELLIPTA doses | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor | Month 1 to Month 3 | ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed. | Percentage of ELLIPTA doses | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor | Month 1 to Month 6 | ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed. | Percentage of ELLIPTA doses | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | Month 4 to Month 6 | ITT Population. Only those participants with rescue data observed/imputed at the specified time points were analyzed. | Percentage of rescue free days | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | Month 4 to Month 6 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Doses of rescue medication | MEAN |
| SECONDARY | Change From Baseline in Asthma Control Test (ACT) Total Score | Baseline and Month 6 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6 | Month 6 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6 | Baseline and Month 6 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | 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 | Baseline and Month 6 | ITT Population | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 andCohort 5: no Data Supplied to Participant or HCP) | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | 80.9 | Standard Error 3.19 | Percentage of ELLIPTA doses | |
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 andCohort 5: no Data Supplied to Participant or HCP) | Cohort 5: No Data Supplied to Par or HCP | 69.0 | Standard Error 3.19 | Percentage of ELLIPTA doses | |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor | Cohort 2: Data on Maintenance Use Supplied to Par | 77.2 | Standard Error 3.04 | Percentage of ELLIPTA doses | |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | 78.3 | Standard Error 3.11 | Percentage of ELLIPTA doses | |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | 77.1 | Standard Error 3.25 | Percentage of ELLIPTA doses | |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor | Cohort 5: No Data Supplied to Par or HCP | 69.0 | Standard Error 3.19 | Percentage of ELLIPTA doses | |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | 85.7 | Standard Error 2.82 | Percentage of ELLIPTA doses | |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor | Cohort 2: Data on Maintenance Use Supplied to Par | 84.2 | Standard Error 2.66 | Percentage of ELLIPTA doses | |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | 82.0 | Standard Error 2.74 | Percentage of ELLIPTA doses | |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | 79.2 | Standard Error 2.78 | Percentage of ELLIPTA doses |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | 87 | |
| Overall Study | STARTED | Cohort 2: Data on Maintenance Use Supplied to Par | 88 | |
| Overall Study | STARTED | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | 88 | |
| Overall Study | STARTED | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | 88 | |
| Overall Study | STARTED | Cohort 5: No Data Supplied to Par or HCP | 86 | |
| Overall Study | COMPLETED | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | 82 | |
| Overall Study | COMPLETED | Cohort 2: Data on Maintenance Use Supplied to Par | 81 | |
| Overall Study | COMPLETED | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | 77 | |
| Overall Study | COMPLETED | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | 78 | |
| Overall Study | COMPLETED | Cohort 5: No Data Supplied to Par or HCP | 81 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events125
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oral candidiasis | Infections and infestations | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | 2 | 87 | |
| other | Oral candidiasis | Infections and infestations | Cohort 2: Data on Maintenance Use Supplied to Par | 0 | 88 | |
| other | Oral candidiasis | Infections and infestations | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | 0 | 88 | |
| other | Oral candidiasis | Infections and infestations | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | 0 | 88 | |
| other | Oral candidiasis | Infections and infestations | Cohort 5: No Data Supplied to Par or HCP | 0 | 86 | |
| other | Oesophageal candidiasis | Infections and infestations | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | 1 | 87 | |
| other | Oesophageal candidiasis | Infections and infestations | Cohort 2: Data on Maintenance Use Supplied to Par | 0 | 88 | |
| other | Oesophageal candidiasis | Infections and infestations | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | 0 | 88 | |
| other | Oesophageal candidiasis | Infections and infestations | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | 0 | 88 | |
| other | Oesophageal candidiasis | Infections and infestations | Cohort 5: No Data Supplied to Par or HCP | 0 | 86 |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | 0 | 87 |
| Total, all-cause mortality | Cohort 2: Data on Maintenance Use Supplied to Par | 0 | 88 |
| Total, all-cause mortality | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | 0 | 88 |
| Total, all-cause mortality | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | 0 | 88 |
| Total, all-cause mortality | Cohort 5: No Data Supplied to Par or HCP | 0 | 86 |
| Total, other adverse events | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | 4 | 87 |
| Total, other adverse events | Cohort 2: Data on Maintenance Use Supplied to Par | 1 | 88 |
| Total, other adverse events | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | 1 | 88 |
| Total, other adverse events | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | 1 | 88 |
| Total, other adverse events | Cohort 5: No Data Supplied to Par or HCP | 2 | 86 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33334936 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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