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

Sponsor
Chiesi Farmaceutici S.p.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT03951714
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
10.8
Actual Duration (Months)
14.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Marketed experience application on adherence
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Aug 12, 2019
Actual Primary Completion Date :
Jul 6, 2020
Actual Study Completion Date :
Jul 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Reference

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

Behavioral: Marketed experience application on adherence
To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence
Experimental: Intervention

Full experience using marketed application, with all functionalities enabled

Behavioral: 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

Primary Outcome Measures

  1. Change from Baseline in adherence rate to entire treatment period [From baseline to end of participation (up to 3 months)]

    Adherence Rate of doses correctly taken twice daily

Other Outcome Measures

  1. Asthma Control Test score [From baseline to end of participation (up to 3 months)]

    Change from Baseline

  2. Test of the Adherence to Inhalers score [From baseline to end of participation (up to 3 months)]

    Change from Baseline

  3. Percentage of days without intake of rescue medication [From baseline to end of participation (up to 3 months)]

    Change from Baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barlow Medical Centre Manchester United Kingdom M20 2RN

Sponsors and Collaborators

  • Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Annaliese Linnhoff, Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT03951714
Other Study ID Numbers:
  • CLI-01535AA1-01
First Posted:
May 15, 2019
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Chiesi Farmaceutici S.p.A.
Post-market study
Additional relevant MeSH terms:
Asthma

Study Results

No Results Posted as of Jul 1, 2021