Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmat… (NCT03951714) | Clinical Trial Compass
CompletedNot Applicable
Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmatic Patient's Adherence
United Kingdom160 participantsStarted 2019-08-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in adherence rate to entire treatment period
Timeframe: From baseline to end of participation (up to 3 months)