Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 years or older, at the time of signing the informed consent. 2. Subjects with documented physician diagnosis of asthma as their primary respiratory disease. 3. Asthma Control Test (ACT) score 6 months with =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. 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 2. History of life threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months 3. A lower respiratory tract infection within 7 days of the screening visit. 4. Concurrent diagnosis of COPD or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. 5. History of hypersensitivity/intolerance to any components of the study inhalers (e.g., 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. 6. 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. 7. Patient who have ever received treatment with biological based therapy e.g. omalizumab, mepolizumab, for asthma 8. 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 9. 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 Propeller Health employee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of 6 months use of the CIS on adherence to ELLIPTA maintenance therapy when both the subject and the HCP are supplied with data from the maintenance sensor versus no data supplied to the subject and HCP (Arm 1 vs Arm 5);Secondary Objective: To compare the effect of 6 months use of the CIS on adherence to ELLIPTA maintenance therapy for the following aspects of the CIS: -Maintenance data only supplied to subjects versus no data supplied to the subject (Arm 2 vs Arm 5) -Rescue and Maintenance data supplied to subject and HCP versus no data supplied to the subject and HCP (Arm 3 vs Arm 5) -Rescue and Maintenance data only supplied to subject versus no data supplied to the subject (Arm 4 vs Arm 5) To compare the effect of the CIS on adherence to ELLIPTA maintenance therapy of the individual CIS treatment arms versus no data supplied to the subject and HCP. To evaluate the effect of 6 months use of the CIS on a subject’s rescue medicine usage To evaluate the effect of 6 months use with the CIS on a subject’s asthma control;Primary end point(s): Percentage of ELLIPTA doses taken (daily adherence1.) between the beginning of month 4 and the end of month 6 as determined by the maintenance sensor;Timepoint(s) of evaluation of this end point: BMD assessment between Visit 1 and Visit 2 and every 6 months following Visit 2 (i.e., Visits 4, 6, 8, 10, 12, 14) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Percentage of ELLIPTA doses taken (daily adherence1.) between the beginning of month 4 and the end of month 6 as determined by the maintenance sensor -Percentage of ELLIPTA doses taken (daily adherence1.) between the beginning of month 1 and the end of month 3 -Percentage of ELLIPTA doses taken (daily adherence) between the beginning of month 1 and the end of month 6 -Percentage of rescue free days measured between the beginning of month 4 and the end of month 6 as determined by the rescue sensor records of date, time, and number of inhaler actuations. -Total rescue use measured between the beginning of month 4 and the end of month 6 as determined by the rescue sensor records of date, time, and number of inhaler actuations. -Change from baseline (Randomisation) in ACT total score at Month 6, measured at baseline (Visit 2, 3 or 4) and Month 6 (Visit10) -Percentage of patients becoming controlled as defined as an Asthma Control Test score =20 at Month 6 (Visit 10) -Percentage of patients with an increase from baseline = 3 in ACT total score at Month 6 (Visit 10);Timepoint(s) of evaluation of this end point: BMD assessment between Visit 1 and Visit 2 and every 6 months following Visit 2 (i.e., Visits 4, 6, 8, 10, 12, 14) | — |
Countries
Canada, France, Germany, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed