CONNected Electronic Inhalers Asthma Control Trial 3 (*CONNECT 3*), a 24-Week Treatment, Multicenter, Open Label, Randomized, Parallel Group Comparison Study of Standard of Care Treatment Versus the Budesonide/Formoterol Digihaler Digital System, to Optimize Outcomes in Adult Patients with Asthma
- Conditions
- Asthma10038716
- Registration Number
- NL-OMON53851
- Lead Sponsor
- PRA Group BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 95
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: 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the proportion of patients for the DS and SoC groups<br /><br>achieving well-controlled asthma as defined by an ACT score of greater than or<br /><br>equal to 20, or a clinically important improvement in asthma control as defined<br /><br>by an increase of at least 3 ACT units from baseline at the end of the 24-week<br /><br>treatment period.</p><br>
- Secondary Outcome Measures
Name Time Method