Asthma
Conditions
Keywords
Post-market study
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.
Interventions
BEHAVIORALMarketed experience application on adherence
To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test score | From baseline to end of participation (up to 3 months) | Change from Baseline |
| Test of the Adherence to Inhalers score | From baseline to end of participation (up to 3 months) | Change from Baseline |
| Percentage of days without intake of rescue medication | From baseline to end of participation (up to 3 months) | Change from Baseline |
Countries
United Kingdom
Outcome results
None listed