Clinical trial NCT03951714: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Post-market study
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2019-05-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline in adherence rate to entire treatment period
timeFrame: From baseline to end of participation (up to 3 months)
Secondary outcomes:
Other outcomes:
measure: Asthma Control Test score
timeFrame: From baseline to end of participation (up to 3 months)
measure: Test of the Adherence to Inhalers score
timeFrame: From baseline to end of participation (up to 3 months)
measure: Percentage of days without intake of rescue medication
timeFrame: From baseline to end of participation (up to 3 months)
Locations:
city: Manchester
country: United Kingdom
facility: Barlow Medical Centre
Study officials:
affiliation: Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde
name: Annaliese Linnhoff
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.