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

Chiesi

Status

Completed

Conditions

Asthma

Treatments

Behavioral: Marketed experience application on adherence

Study type

Interventional

Funder types

Industry

Identifiers

NCT03951714

CLI-01535AA1-01

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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