A Study on Inhaler Adherence to Improve Poor Asthma Control
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Beaumont Hospital
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Mean rate of actual Adherence to preventer medication
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Professor Richard Costello
Professor of Medicine
Beaumont Hospital
Eligibility Criteria
Inclusion Criteria
- •Must be willing to give voluntary informed consent
- •Must have a clinical diagnosis of asthma supported by objective measures, one of the following by FEV1/FVC \<70% and FEV1 \<80% or - a 12% change in FEV1 following administration of a beta-agonist or spontaneously over 1 year period, a positive bronchial provocation test, or a 10% variability in PEF within a 7 day period.
- •Must have a bronchodilator FEV1 \> 40% and \<80% in the past 1 year
- •Current unstable asthma i.e. ACT score ≤ 19 at enrolment despite already being managed with GINA step 3-5 therapy.
- •One or more courses of oral corticosteroids in the prior year, or a hospitalization or ED attendance with an asthma exacerbation in the last year
- •Age 18 years or older at time of consent.
- •Capable of understanding and complying with the requirements of the protocol, including the ability to attend for all required visits.
- •Able and willing to take inhaled medication via a Diskus.
- •In the opinion of the investigator suitable for use of a salmeterol/fluticasone Diskus inhaler or already using a salmeterol/fluticasone inhaler.
Exclusion Criteria
- •Have used any investigational product or device within 3 months of the enrolment visit.
- •Have known previous sensitivity to Seretide (salmeterol/fluticasone).
- •Have a known significant (in the opinion of the investigator) concurrent medical disease, pregnancy that might mean that the participant cannot complete the study.
- •Be taking omalizumab or other biological agent used in the treatment of asthma
- •Concurrent treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors; Ketoconazole and Ritonavir.
- •Current smokers and ex-smokers with a greater than 20 pack year history of cigarette smoke
Outcomes
Primary Outcomes
Mean rate of actual Adherence to preventer medication
Time Frame: week 20 through 32
This study will focus on severe asthma patients, who remain uncontrolled and with frequent exacerbations requiring oral steroids and have an Asthma control test (ACT) score of \<19 on enrollment.
The between-group difference in the proportion of patients prescribed guideline appropriate medication at the end of the study.
Time Frame: week 20 through 32
The appropriateness of the prescribed therapy will be verified for each participant after study completion using all available adherence and PEF data. Between-group differences will be further broken down by the following: * The proportion of participants prescribed add-on therapy (e.g. Monoclonal antibody therapy) * The proportion of participants whose ICS/LABA dose was increased * The proportion of participants whose ICS/LABA dose was reduced
Secondary Outcomes
- Change in PEF variability(Baseline to week 32)
- Change in Asthma Control Test scores at week 32(Baseline to week 32)
- The proportion of patients who are non-adherent and remain uncontrolled(First 8 weeks of the study and week 20 to 32)
- The proportion of patients who are refractory to treatment(First 8 weeks of the study and week 20 to 32)
- Cost-effectiveness and economic evaluation of the INCA educational intervention(First 8 weeks of the study and week 20 to 32)
- Change in AQLQ(Baseline to week 32)
- Exacerbations over study period(Baseline to week 32)
- To compare the proportion of patients who were clinically stable(First 8 weeks of the study and week 20 to 32)
- Relationship of biomarkers with adherence(Baseline to week 32)
- The proportion of patients with inhaler related side effects(First 8 weeks of the study and week 20 to 32)