A Study to Test if Using the BF Digihaler System is Effective in Getting Better Control of Asthma in Adult Patients Compared to Usual Care
- Conditions
- AsthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-003951-41-NL
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method