Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:48 PM
Study NCT ID:
NCT02307669
Status:
UNKNOWN
Last Update Posted:
2019-08-16
First Post:
2014-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inhaler Adherence in Severe Unstable Asthma
Sponsor:
Beaumont Hospital
Organization:
Study Overview
Official Title:
A Study on Inhaler Adherence to Improve Poor Asthma Control
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INCA-SUN
Brief Summary:
The investigators hypothesize that aligning digital data on PEF and adherence with the patient's own clinical course achieves better asthma control and identifies risks for future loss of control, compared to current best practice. The study has an adherence optimisation phase, week 1-12 followed by a medication management phase, week 12 to week 32.
The investigators will compare two asthma education interventions, standard Guideline recommended practice and feedback from the individual's own INCA device, which assesses inhaler adherence and relates adherence with changes in PEF and symptom scores over time.
The study has two co-primary endpoints, one will be a comparison of the adherence to therapy and the other will be a comparison of the appropriateness of medication prescriptions between the two study groups.
The investigators will compare two asthma education interventions, standard Guideline recommended practice and feedback from the individual's own INCA device, which assesses inhaler adherence and relates adherence with changes in PEF and symptom scores over time.
The study has two co-primary endpoints, one will be a comparison of the adherence to therapy and the other will be a comparison of the appropriateness of medication prescriptions between the two study groups.
Detailed Description:
The investigators hypothesize that aligning adherence, inhaler technique and digitally recorded PEF to inform patients and as the basis of prescribing decisions achieves better inhaler adherence and technique and also allows physicians to make appropriate prescribing decisions, compared to current best practice.
The investigators will compare two asthma education interventions, standard BTS/SIGN Guideline recommended practice and feedback from the individual's own INCA device, which assesses inhaler adherence and relates adherence with changes in PEF and symptom scores over time.
This education phase is followed by a medication optimisation phase (weeks 12-32) in which there are 3 cycles of medication optimisation guided by a digital script. The script either adjusts the medications following the GINA recommendation or uses the GINA recommendation but is supplemented with data on adherence and PEF that are recorded to digital, time-stamped, recording devices.
The aim of the study is to improve and maintain adherence to preventer therapy, so that medication and other costs as well as the quality of life, exacerbation rates are optimal.
The investigators will compare two asthma education interventions, standard BTS/SIGN Guideline recommended practice and feedback from the individual's own INCA device, which assesses inhaler adherence and relates adherence with changes in PEF and symptom scores over time.
This education phase is followed by a medication optimisation phase (weeks 12-32) in which there are 3 cycles of medication optimisation guided by a digital script. The script either adjusts the medications following the GINA recommendation or uses the GINA recommendation but is supplemented with data on adherence and PEF that are recorded to digital, time-stamped, recording devices.
The aim of the study is to improve and maintain adherence to preventer therapy, so that medication and other costs as well as the quality of life, exacerbation rates are optimal.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: