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

NCT ID: NCT03951714

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-12
• Study Completion Date: 2020-07-06

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Reference

Control experience using marketed application to record medication intake without reminders from the app

Group Type: OTHER

Marketed experience application on adherence

Intervention Type: BEHAVIORAL

To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence

Intervention

Full experience using marketed application, with all functionalities enabled

Group Type: EXPERIMENTAL

Marketed experience application on adherence

Intervention Type: BEHAVIORAL

To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence

Interventions

Marketed experience application on adherence

To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annaliese Linnhoff

Role: PRINCIPAL_INVESTIGATOR

Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde

Locations

Barlow Medical Centre

Manchester, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35691614 (View on PubMed)

Related Links

https://www.chiesi.com/en/chiesi-clinical-study-register/

Structured Summary Data Results on Chiesi Clinical Study Register

Other Identifiers

CLI-01535AA1-01

Identifier Type: -

Identifier Source: org_study_id