Asthma
Conditions
Interventions
Budesonide/formoterol 160/4.5 mcg powder for oral inhalation
1-2 inhalations, twice daily
1 additional inhalation as needed in response to
symptoms. Not more than 6 inhalations should be taken on any single occasion. A
total daily dose of more than 8 inhalations is not normally needed
however, a
total daily dose of up to 12 inhalations could be used for a limited period.
Patients using more than 8 inhalations daily should be strongly recommended to
seek medical advice.
Sponsors
PRA Group BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients may be included in the study only if they meet all of the following 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.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients will be excluded from participating in this study if they meet any of the following 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| (#1) This secondary endpoint 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 to 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 LAMA or biologics • frequency of intervention to manage comorbid conditions associated with poor asthma control (gastroesophageal reflux disease, sinusitis, etc.) (#2) This secondary endpoint 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. (#3) This secondary endpoint 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. (#4) This secondary endpoint 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. (#5) This secondary endpoint 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 | — |
Countries
Netherlands
Outcome results
None listed