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OpenTrials
Completed

NCT Number: NCT03951714

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barlow Medical Centre

Manchester, M20 2RN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Marketed experience application on adherence

Behavioral

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

Primary outcomes

  1. Change from Baseline in adherence rate to entire treatment period

    Time frame: From baseline to end of participation (up to 3 months)

    Adherence Rate of doses correctly taken twice daily

Other outcomes

  1. Asthma Control Test score

    Time frame: From baseline to end of participation (up to 3 months)

    Change from Baseline

  2. Test of the Adherence to Inhalers score

    Time frame: From baseline to end of participation (up to 3 months)

    Change from Baseline

  3. Percentage of days without intake of rescue medication

    Time frame: From baseline to end of participation (up to 3 months)

    Change from Baseline

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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

Acronym: ADVICE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 15, 2019
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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