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Trial record 1 of 2 for:    207040
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A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03380429
Recruitment Status : Completed
First Posted : December 21, 2017
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: RELVAR/BREO Drug: Salbutamol Device: Smart phone app Device: HCP Dashboard Device: Sensors Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI. Clip-on sensors will be attached to both inhalers which will provide data on maintenance therapy and rescue medication use to the subjects and their HCP. Subjects will be randomized into five treatment arms in a ratio of 1:1:1:1:1 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomised, Parallel Group Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Relvar/Breo ELLIPTA Therapy, in Asthmatic Subjects With Poor Control
Actual Study Start Date : January 31, 2018
Actual Primary Completion Date : January 24, 2019
Actual Study Completion Date : January 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Data on Maintenance use supplied to Subject and HCP
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
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Smart phone app
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.

Device: HCP Dashboard
The information from sensors will be reviewed by the HCP via an online dashboard.

Device: Sensors
Clip-on sensors will be fitted to electronically record the actuation data.

Experimental: Data on Maintenance use supplied to Subject
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
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Smart phone app
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.

Device: Sensors
Clip-on sensors will be fitted to electronically record the actuation data.

Experimental: Data on Maintenance and Rescue use supplied to Subject and HCP
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
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Smart phone app
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.

Device: HCP Dashboard
The information from sensors will be reviewed by the HCP via an online dashboard.

Device: Sensors
Clip-on sensors will be fitted to electronically record the actuation data.

Experimental: Data on Maintenance and Rescue use supplied to Subject
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
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Smart phone app
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.

Device: Sensors
Clip-on sensors will be fitted to electronically record the actuation data.

Active Comparator: No data supplied to Subject or HCP
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
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Sensors
Clip-on sensors will be fitted to electronically record the actuation data.




Primary Outcome Measures :
  1. 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") [ Time Frame: 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 Outcome Measures :
  1. Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor [ Time Frame: 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.

  2. Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor [ Time Frame: 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.

  3. Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor [ Time Frame: 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.

  4. Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor [ Time Frame: 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.

  5. Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor [ Time Frame: 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.

  6. Change From Baseline in Asthma Control Test (ACT) Total Score [ Time Frame: 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.

  7. Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6 [ Time Frame: 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.

  8. Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6 [ Time Frame: 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.

  9. 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged 18 years or older, at the time of signing the informed consent.
  • Subjects with documented physician diagnosis of asthma as their primary respiratory disease.
  • ACT score <20 at screening visit.
  • Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = [cigarettes per day smoked/20] multiplied by number of years smoked).
  • Male or female subjects will be included. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: (i) Not a woman of childbearing potential (WOCBP). (ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days] after the last dose of study treatment.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and protocol.
  • Subject understands and is willing, able, and likely to comply with study procedures and restrictions.
  • Subject must be able to read in a language supported by the smart phone app in their region.
  • Subject must have been on maintenance therapy (Fixed dose combination ICS/LABA) for 3 months, cannot have changed dose in the month prior to screening and be able to change to an equivalent dose of RELVAR/BREO for the duration of the study. Other background asthma medication such as anti-leukotrienes and oral corticosteroids are permitted provided the dose has been stable for 1 month prior to screening.
  • Subject must be able to change to Salbutamol/Albuterol MDI rescue for the duration of the study and judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
  • Subject must have their own Android or iPhone operating system (IOS) smart phone and a data package suitable for the installation and running of the app and sending and receiving data. Data used by the CIS is approximately 1 megabyte (MB) per month as a maximum; this is less data than a 1 minute video streamed from YouTube (2MB).
  • Subjects must be willing and able to download the app on their personal smart phone and keep it turned on for the duration of the study. This will also require Bluetooth to be turned on for duration of the study. Subjects will also have to turn on mobile data for the app for the duration of study; unless travelling and when extra data roaming costs could be incurred.

Inclusion criteria for randomization:

  • ACT score <20 at randomization visit (visit 2).

Exclusion Criteria:

  • Subjects with a known or suspected alcohol or drug abuse which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement.
  • History of life threatening asthma: Defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months.
  • A lower respiratory tract infection within 7 days of the screening visit.
  • Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
  • History of hypersensitivity/intolerance to any components of the study inhalers (example, lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
  • Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study.
  • Subjects who have ever received treatment with biological based therapy example, omalizumab, mepolizumab, for asthma.
  • Subjects who have received an investigational drug and/or medical device within 30 days of entry into this study (Screening), or within five drug half-lives of the investigational drug, whichever is longer.
  • A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, employee of the participating investigator, or any family member of a Propeller Health employee.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380429


Locations
Show Show 66 study locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] September 10, 2018
Statistical Analysis Plan  [PDF] February 21, 2019

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03380429    
Other Study ID Numbers: 207040
2017-002266-45 ( EudraCT Number )
First Posted: December 21, 2017    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
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.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by GlaxoSmithKline:
Connected Inhaler System
Metered Dose Inhaler
ELLIPTA
RELVAR/BREO
Dry Powder Inhaler
Salbutamol
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action