Inhaler Adherence in Severe Unstable Asthma (INCA-SUN)

Beaumont Hospital

Status: Unknown

Conditions: Asthma

Treatments: Behavioral: INCA feedback; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02307669

INCA-Sun

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups, including a placebo group

Routine inhaler adherence care

Placebo Comparator group

Description:

Normal Care group This management is based on the inhaler training recommendations of the BTS/SIGN group (http://www.brit-thoracic.org.uk/Portals/0/Guidelines/AsthmaGuidelines/sign101%20Jan%202012.pdf) and medication management of the GINA management strategy. The core features of the "usual care" group are: 1. The patient's inhaler technique will be checked using a checklist, at each visit. If there are errors these will be corrected using teach-to-goal principals. 2. Adherence will be discussed and barriers to adherence addressed, using motivational interview techniques. 3. Written action plans for managing asthma, based on changes in PEF and symptoms will be given. 4. In follow up, medication changes in response to the above will be directed by these, as suggested by GINA management guidelines using a standardised digital script.

Treatment:

Behavioral: Usual Care

INCA feedback

Active Comparator group

Description:

1. The patient's treatment goal is established and used as the focus of the conversation. 2. Data from the INCA device including (1) time of use, (2) handling proficiency and (3) inhalation flow rates are discussed, with three graphs as shown in the appendix and derived as discussed. These are aimed to enhance the value of the inhaler. 3. Data from the electronic PEF and AQLQ are correlated with digitally recorded adherence so that these can be used to account for improvements or declines in these measures. 4. In follow up, medication changes in response to the above (adherence, PEF, ACT and exacerbations) are made using a standardised digital script.

Treatment:

Behavioral: INCA feedback