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

Study Identifier:
CLI-01535AA1-01
ClinicalTrials.gov Identifier:
NCT03951714
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Trial Documents

Scientific Result Summary
Available Languages: English
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Study Details

Medical Condition
  • Asthma
Study Drug
    Date
    Aug 2019 - Jul 2020
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 18+ years
    Requirements Information
    Inclusion and Exclusion 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
    Healthy Volunteers
    No

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Barlow Medical Centre
    Manchester, United Kingdom, M20 2RN
    Status
    N/A

    Study 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.