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

NCT03951714 | Completed

• 1 other identifier: CLI-01535AA1-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

Post-market study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Asthma Control Test score

  From baseline to end of participation (up to 3 months)

• Test of the Adherence to Inhalers score

  From baseline to end of participation (up to 3 months)

• Percentage of days without intake of rescue medication

  From baseline to end of participation (up to 3 months)

Study Arms (2)

Reference

OTHER

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

Behavioral: Marketed experience application on adherence

Intervention

EXPERIMENTAL

Full experience using marketed application, with all functionalities enabled

Behavioral: Marketed experience application on adherence

Interventions

Marketed experience application on adherence BEHAVIORAL

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

Intervention; Reference

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Barlow Medical Centre

Manchester, M20 2RN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35691614 DERIVED

Related Links

• Structured Summary Data Results on Chiesi Clinical Study Register

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Annaliese Linnhoff

  Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: August 12, 2019
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)