Clinical trial NCT02307669: Inhaler Adherence in Severe Unstable Asthma
Official title: A Study on Inhaler Adherence to Improve Poor Asthma Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Adherence
Inhaler
GINA
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Mean rate of actual Adherence to preventer medication
timeFrame: week 20 through 32
measure: The between-group difference in the proportion of patients prescribed guideline appropriate medication at the end of the study.
timeFrame: week 20 through 32
Secondary outcomes:
measure: Cost-effectiveness and economic evaluation of the INCA educational intervention
timeFrame: First 8 weeks of the study and week 20 to 32
measure: Change in Asthma Control Test scores at week 32
timeFrame: Baseline to week 32
measure: Change in PEF variability
timeFrame: Baseline to week 32
measure: Change in AQLQ
timeFrame: Baseline to week 32
measure: Exacerbations over study period
timeFrame: Baseline to week 32
measure: To compare the proportion of patients who were clinically stable
timeFrame: First 8 weeks of the study and week 20 to 32
measure: Relationship of biomarkers with adherence
timeFrame: Baseline to week 32
measure: The proportion of patients who are refractory to treatment
timeFrame: First 8 weeks of the study and week 20 to 32
measure: The proportion of patients who are non-adherent and remain uncontrolled
timeFrame: First 8 weeks of the study and week 20 to 32
measure: The proportion of patients with inhaler related side effects
timeFrame: First 8 weeks of the study and week 20 to 32
Other outcomes:
measure: Patient identified goal
timeFrame: Baseline to week 32
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: RCSI
name: Richard w Costello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mokoka MC, Lombard L, MacHale EM, Walsh J, Cushen B, Sulaiman I, Carthy DM, Boland F, Doyle F, Hunt E, Murphy DM, Faul J, Butler M, Hetherington K, Mark FitzGerald J, Boven JFV, Heaney LG, Reilly RB, Costello RW. In patients with severe uncontrolled asthma, does knowledge of adherence and inhaler technique using electronic monitoring improve clinical decision making? A protocol for a randomised controlled trial. BMJ Open. 2017 Jun 15;7(6):e015367. doi: 10.1136/bmjopen-2016-015367.
citation: Butler CA, Heaney LG. Fractional exhaled nitric oxide and asthma treatment adherence. Curr Opin Allergy Clin Immunol. 2021 Feb 1;21(1):59-64. doi: 10.1097/ACI.0000000000000704.