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

Asthma Clinical Trial

— ADVICE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951714
• Other study ID #: CLI-01535AA1-01
• Status: Completed
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: July 6, 2020

Study information

• Verified date: June 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 6, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Barlow Medical Centre	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)
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)

External Links

•   Structured Summary Data Results on Chiesi Clinical Study Register