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

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

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Marketed experience application on adherence

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M20 2RN
    • Barlow Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Test score	Change from Baseline	From baseline to end of participation (up to 3 months)
Test of the Adherence to Inhalers score	Change from Baseline	From baseline to end of participation (up to 3 months)
Percentage of days without intake of rescue medication	Change from Baseline	From baseline to end of participation (up to 3 months)

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Annaliese Linnhoff, Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde

Publications and helpful links

General Publications

• Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.

Helpful Links

• Structured Summary Data Results on Chiesi Clinical Study Register

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): July 6, 2020
• Study Completion (Actual): July 6, 2020

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Post-market study
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CLI-01535AA1-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes