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 enrollmentAugust 12, 2019

ConditionsAsthma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Asthma
Sponsor: Chiesi Farmaceutici S.p.A.
Enrollment: 160
Locations: 1
Primary Endpoint: Change from Baseline in adherence rate to entire treatment period
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 12, 2019

End Date

July 6, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chiesi Farmaceutici S.p.A.

Responsible Party

Sponsor

Eligibility Criteria

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