| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| E.1.1.1 | Medical condition in easily understood language | |
| E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
| MedDRA Classification |
| 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 | | The primary objective of this study is to demonstrate the effectiveness of the digital system compared to the Standard of Care group | |
| E.2.2 | Secondary objectives of the trial | The secondary objective (#1) is to describe the asthma management actions by Health Care Professionals for all patients in both groups.
The secondary objective (#2) is to evaluate adherence patterns to maintenance treatment (BF Digihaler) in the Digital System (DS) group.
The secondary objective (#3) is to evaluate work productivity and activity impairment in asthma patients in both groups.
The secondary objective (#4) is to assess the usability and acceptability of the Digital System by patients in the DS group and the investigational center personnel.
The secondary objective (#5) is to evaluate the safety of BF Digihaler DS.
| |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria | a. The patient is 18 years or older at the time of screening.
b. The patient has a documented diagnosis of asthma established at the investigational center at the time of informed consent or the investigator confirms a diagnosis of asthma.
c. The patient is currently on treatment with a moderate- to high-dose ICS with LABA.
d. The patient has an ACT score of less than 19 at the screening/baseline visit.
e. The patient is willing to discontinue all other maintenance ICS with LABA medications and rescue medications and replace them with the study-provided BF Digihaler as MART for the duration of the trial, if randomized to the BF Digihaler DS group. All other asthma maintenance medications, except for ICS with LABA, may be continued.
f. The patient can read fluently and communicate in United Kingdom English, Dutch, or German, as applicable, and is familiar with and is willing to use his/her own mobile phone that meets the minimum App requirements and download and use the App.
g. The patient is able to provide written informed consent.
h. The patient must be willing and able to comply with study requirements and restrictions and to remain at the investigational center for the required duration during the study period, and willing to return to the investigational center for the follow-up procedures and assessments as specified in this protocol. | |
| E.4 | Principal exclusion criteria | a. The patient has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma, which in the view of the investigator would preclude participation.
b. The patient has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient’s ability to participate in this study.
c. The patient is currently using or has used, in the 12 months prior to enrollment, a digital inhaler system designed to monitor inhaler usage such as, but not limited to, the Propeller Health, Adherium, or Amiko systems.
d. The patient has a diagnosis of chronic obstructive pulmonary disease (COPD) or asthma-COPD overlap (ACO).
e. The patient is a current smoker or has a greater than 10 pack-year history of smoking.
f. The patient was treated for asthma exacerbation, including hospitalization or emergency visits, in the last 30 days.
g. The patient is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
h. The patient has any treatment with biologics for asthma (eg, omalizumab, anti interleukin (IL)5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.
i. The patient has a known hypersensitivity to any components of the IMPs stated in this protocol. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | | The primary endpoint is the proportion of patients for the DS and SoC groups achieving well-controlled asthma as defined by an ACT score of greater than or equal to 20, or a clinically important improvement in asthma control as defined by an increase of at least 3 ACT units from baseline at the end of the 24-week treatment period. | |
| E.5.1.1 | Timepoint(s) of evaluation of this end point | | From baseline at the end of the 24-week treatment period | |
| E.5.2 | Secondary end point(s) | Secondary endpoint #1 is the frequency of clinically driven assessments and types of interventions done to improve asthma control including:
number of discussions regarding inhaler technique
number of discussions regarding adherence
number of adjustments of therapy including:
- changes for current inhaler therapy (stepping up and stepping down)
- change to different inhaled medication
- additional inhaled medication
- addition of a systemic corticosteroid medication for asthma or another controller, including a long-acting muscarinic antagonist (LAMA) or biologics
frequency of intervention to manage comorbid conditions associated with poor asthma control (gastroesophageal reflux disease, sinusitis, etc.)
Secondary endpoint #2 is the change from baseline in adherence to the BF Digihaler DS when prescribed as maintenance treatment, defined as the proportion of actual inhalation doses taken out of the total number of inhalation doses prescribed over the 24-week treatment period.
Secondary endpoint #3 is the change from baseline measured by the WPAI questionnaire, completed by patients in both groups, at baseline and at the end of the 24-week treatment period.
Secondary endpoint #4 is the assessment of the DS (BF Digihaler, App, DHP [Cloud solution], and HCP-facing dashboard) acceptability and usability, utilizing the SUS, completed by the patients in the DS group, and the investigational center personnel at the End of treatment visit.
Secondary endpoint #5 is the reporting of adverse events related to BF Digihaler DS at participating investigational centers.
The safety endpoints for this study include the following for all patients in both groups:
adverse event data
adverse device effect data | |
| E.5.2.1 | Timepoint(s) of evaluation of this end point | |
| 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 | No |
| E.6.5 | Efficacy | Yes |
| 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 | No |
| 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 | 2 |
| 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 | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 28 |
| 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 | | Netherlands | | Germany | | Ireland | | United Kingdom | |
| 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 | | End of study is defined as the follow-up telephone call for the last patient | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
