Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmatic Patient's Adherence

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Marketed experience application on adherence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Reference<br>Control experience using marketed application to record medication intake without reminders from the app | Behavioral: Marketed experience application on adherence<br>* To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence<br>|
| Experimental: Intervention<br>Full experience using marketed application, with all functionalities enabled | Behavioral: Marketed experience application on adherence<br>* To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in adherence rate to entire treatment period | Adherence Rate of doses correctly taken twice daily | From baseline to end of participation (up to 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-market study