NCT03951714CompletedNot Applicable
12-wks Randomised Controlled Trial to Explore the Effect of a Smartphone App. Connected to an Add-on Device System Fitted on pMDI Inhaler on Adherence to Medications Intake and Clinical Outcomes in Difficult-to-treat Asthmatic Patients
Chiesi Farmaceutici S.p.A.1 site in 1 country160 target enrollmentStarted: August 12, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change from Baseline in adherence rate to entire treatment period
Study Overview
Brief Summary
The purpose of this Study is to assess the effect of a smartphone application connected to an add-on device system fitted on Pressured Metered Dose Inhaler (PMDI) on adherence to take medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient's written informed consent obtained prior to any study-related procedures
- •Male or female patient aged 18 years and above
- •Patient with established diagnosis of asthma for at least 6 months
- •Patient on maintenance therapy (Fixed dose combination ICS/LABA) with high dose of ICS
- •Patient with ACT score <20 at screening and at randomization
- •Non- or ex-smoker who smoked ≤ 10 Pack-years prior to screening
- •Patient must have their own Android® or iPhone operating system (IOS) smartphone
- •Ability to use the pMDI device correctly
Exclusion Criteria
- •Patient with an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 to 3 month prior to screening
- •Patient with a history of near-fatal asthma
- •Clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, psychiatric or any other disorder that would put the safety of the subject at risk through participation, or which would affect the analysis
- •Patient not able to be compliant with the study requirements.
- •Patient with a BMI > 40
- •Patient working on night shifts
- •Patient participating in the clinical phase of an interventional trial or have done so within the last 30 days prior to screening.
- •Patient who has an already planned major surgery or hospitalization
- •Female patient who is pregnant or lactating or who plans to become pregnant in the next 4 months.
- •Patient with a history of hypersensitivity to any of the components of Foster pMDI
Arms & Interventions
Reference
Other
Control experience using marketed application to record medication intake without reminders from the app
Intervention: Marketed experience application on adherence (Behavioral)
Intervention
Experimental
Full experience using marketed application, with all functionalities enabled
Intervention: Marketed experience application on adherence (Behavioral)
Outcomes
Primary Outcomes
Change from Baseline in adherence rate to entire treatment period
Time Frame: From baseline to end of participation (up to 3 months)
Adherence Rate of doses correctly taken twice daily
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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