AsthmaADVICENCT03951714
Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmatic Patient's Adherence
A study testing Marketed experience application on adherence in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Marketed experience application on adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2019to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Asthma
- Being tested
- Marketed experience application on adherence
- Keywords
- Post-market study
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed experience application on adherenceBehavioural
To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence
| Study group | Role | What they receive |
|---|---|---|
| Reference | Other | Control experience using marketed application to record medication intake without reminders from the app Receives: Behavioral: Marketed experience application on adherence |
| Intervention | Experimental | Full experience using marketed application, with all functionalities enabled Receives: Behavioral: Marketed experience application on adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in adherence rate to entire treatment period
Adherence Rate of doses correctly taken twice daily
Measured: From baseline to end of participation (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start12 Aug 2019
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annaliese Linnhoff, Principal investigator, Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951714
- Sponsor's protocol ID
- CLI-01535AA1-01
- Acronym
- ADVICE
- Status last verified
- Jun 2021
- First submitted
- 14 May 2019
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35691614
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03951714
- Acronym / sponsor ID
- ADVICE / CLI-01535AA1-01
- Conditions
- Asthma
- Keywords
- Post-market study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference | Other | Behavioral: Marketed experience application on adherenceControl experience using marketed application to record medication intake without reminders from the app |
| Intervention | Experimental | Behavioral: Marketed experience application on adherenceFull experience using marketed application, with all functionalities enabled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marketed experience application on adherenceTo evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence | Behavioural | Intervention, Reference |
Primary outcome
Change from Baseline in adherence rate to entire treatment period
Time frame: From baseline to end of participation (up to 3 months)
Adherence Rate of doses correctly taken twice daily
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 35691614Chan 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.
- Structured Summary Data Results on Chiesi Clinical Study RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annaliese Linnhoff principal investigator
Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed experience application on adherence in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in adherence rate to entire treatment period (time frame: From baseline to end of participation (up to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03951714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.