Have you or your loved ones been diagnosed with asthma?

You may be eligible to participate in a asthma clinical trial.

Have you or your loved ones been diagnosed with asthma? You may be eligible to participate in a asthma clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Asthma Clinical Trial in Manchester

NCT03951714 | Interventional

Have you or your loved ones been diagnosed with asthma?

You may be eligible to participate in a asthma clinical trial.

Have you or your loved ones been diagnosed with asthma? You may be eligible to participate in a asthma clinical trial.

Completed

Male & Female

18 Years +

This study has recruited 160 Participants

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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Details for the study

Brief Title

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

Official 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

Brief Summary

The purpose of this Study is to assess the effect of a smartphone application connected to an <br /> add-on device system fitted on Pressured Metered Dose Inhaler (PMDI) on adherence to take <br /> medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients.

Treatments and/or Procedures

Marketed experience application on adherence

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

Asthma Control Test score

Change from Baseline

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

Other

Test of the Adherence to Inhalers score

Change from Baseline

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

Other

Percentage of days without intake of rescue medication

Change from Baseline

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

Study 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