Inhaler Adherence in Severe Unstable Asthma (INCA-SUN)

August 14, 2019 updated by: Professor Richard Costello, Beaumont Hospital

A Study on Inhaler Adherence to Improve Poor Asthma Control

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Routine inhaler adherence care

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.
Behavioral: Usual Care

The core features of the "usual care" group are:

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.

Adherence will be discussed and barriers to adherence addressed, using motivational interview techniques.

Written action plans for managing asthma, based on changes in PEF and symptoms will be given.

In follow up, medication changes in response to the above will be directed by these, as suggested by Guidelines.
Active Comparator: INCA feedback
  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.
Behavioral: INCA feedback
The study team have developed a device which is attached to inhalers that makes an audio recording of the inhaler being used. Analysis of this audio data provides objective evidence of the time of inhaler use, technique of use and the peak inspiratory flow the patient makes each time they use their inhaler. Our preliminary experiences with the information obtained from this device indicate that adherence is poor in patients with severe asthma due to any one the following issues poor time of use, errors in handling and low peak inspiratory flow rates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 20 through 32
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
week 20 through 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness and economic evaluation of the INCA educational intervention
Time Frame: First 8 weeks of the study and week 20 to 32

An economic evaluation of national implementation of the INCA-SUN program will be provided. Data on the cost of the intervention (device, time taken to deliver, cost of training and salary cost of the trainer), medication costs, quality of life, exacerbations and other healthcare utilization and associated costs, such as unscheduled health care visits as well as work productivity losses will be collected alongside the 32-week study.

A cost-effectiveness and cost-utility analysis of the intervention compared to the control arm will be performed. Incremental cost-effectiveness ratios (or ICERS) will be calculated from the data, to estimate how much additional cost is required for an additional unit of benefit.
First 8 weeks of the study and week 20 to 32
Change in Asthma Control Test scores at week 32
Time Frame: Baseline to week 32
ACT scores will be obtained during the study visits.
Baseline to week 32
Change in PEF variability
Time Frame: Baseline to week 32
Differences between the two study groups will be calculated
Baseline to week 32
Change in AQLQ
Time Frame: Baseline to week 32
AQLQ scores will be obtained during the study visits.
Baseline to week 32
Exacerbations over study period
Time Frame: Baseline to week 32
It is hypothesised that with active education, exacerbation frequency can be reduced.
Baseline to week 32
To compare the proportion of patients who were clinically stable
Time Frame: First 8 weeks of the study and week 20 to 32
The proportion of patients who required no daily reliever use in the month prior to study end will be compared.
First 8 weeks of the study and week 20 to 32
Relationship of biomarkers with adherence
Time Frame: Baseline to week 32
A comparison of changes in blood eosinophil's, periostin and Fractional Exhaled Nitric Oxide (FeNO) between the active and control groups will be made.The relationship between 7-day FeNO suppression and clinical and biomarker outcomes will be investigated.10. The relationship between changes in FeNO (characterised into FeNo>45ppb Or FeNO<45ppb) and adherence will also be investigated.
Baseline to week 32
The proportion of patients who are refractory to treatment
Time Frame: First 8 weeks of the study and week 20 to 32
A comparison of the proportion of patients who are refractory, (defined as having actual adherence ≥80%, ≥1 exacerbation, PEF am/pm <80% and ACT ≤19) will be conducted.
First 8 weeks of the study and week 20 to 32
The proportion of patients who are non-adherent and remain uncontrolled
Time Frame: First 8 weeks of the study and week 20 to 32
The proportion of patients who are non-adherent and remain uncontrolled, (i.e. Actual Adherence <80%, PEF am/pm <80% and ACT≤19) between the active and control groups will be compared.
First 8 weeks of the study and week 20 to 32
The proportion of patients with inhaler related side effects
Time Frame: First 8 weeks of the study and week 20 to 32
The proportion of patients with inhaler related side effects including oral candidiasis between the active and control groups will be compared.
First 8 weeks of the study and week 20 to 32

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient identified goal
Time Frame: Baseline to week 32
Proportion of patients reaching stated clinical goal at week 12 and between that period and week 32.
Baseline to week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaumont Hospital

Investigators

  • Principal Investigator: Richard w Costello, MD, RCSI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCA-Sun

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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