E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <20 at screening visit
4. Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = [cigarettes per day smoked/20] x number of years smoked)
5. Male or Female subjects:
A female subject is eligible to participate if she is not pregnant (see Appendix 5 of the study protocol), not breastfeeding, and at least one of the following conditions applies:
(i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 of the study protocol.
OR
(ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 of the study protocol during the treatment period and for at least 5 days] after the last dose of study treatment.
6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
7. Subject understands and is willing, able, and likely to comply with study procedures and restrictions.
8. Subject must be able to read in a language supported by the smart phone app in their region
9. 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.
10. 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.
11. Subject must have their own Android or 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 1MB per month as a maximum; this is less data than a 1 minute video streamed from YouTube (2MB)).
12. 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | 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) |
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E.5.2 | 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) |
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E.5.2.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Evaluate the effect of the Connected Inhaler System (CIS) on adherence |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |