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Inhaler Adherence in Severe Unstable Asthma (INCA-SUN)

Primary Purpose

Asthma

Status

Unknown status

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

INCA feedback

Usual Care

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Adherence, Inhaler, GINA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Beaumont HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Routine inhaler adherence care

INCA feedback

Arm 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: 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 GINA management guidelines using a standardised digital script.

The patient's treatment goal is established and used as the focus of the conversation. 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. 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. In follow up, medication changes in response to the above (adherence, PEF, ACT and exacerbations) are made using a standardised digital script.

Outcomes

Primary Outcome Measures

Mean rate of actual Adherence to preventer medication

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.

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 Outcome Measures

Cost-effectiveness and economic evaluation of the INCA educational intervention

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.

Change in Asthma Control Test scores at week 32

ACT scores will be obtained during the study visits.

Change in PEF variability

Differences between the two study groups will be calculated

Change in AQLQ

AQLQ scores will be obtained during the study visits.

Exacerbations over study period

It is hypothesised that with active education, exacerbation frequency can be reduced.

To compare the proportion of patients who were clinically stable

The proportion of patients who required no daily reliever use in the month prior to study end will be compared.

Relationship of biomarkers with adherence

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.

The proportion of patients who are refractory to treatment

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.

The proportion of patients who are non-adherent and remain uncontrolled

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.

The proportion of patients with inhaler related side effects

The proportion of patients with inhaler related side effects including oral candidiasis between the active and control groups will be compared.

Full Information

NCT ID

NCT02307669

First Posted

April 21, 2014

Last Updated

August 14, 2019

Sponsor

Beaumont Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02307669

Brief Title

Inhaler Adherence in Severe Unstable Asthma

Acronym

INCA-SUN

Official Title

A Study on Inhaler Adherence to Improve Poor Asthma Control

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

January 1, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beaumont Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Adherence, Inhaler, GINA

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Routine inhaler adherence care

Arm Type

Placebo Comparator

Arm Description

Arm Title

INCA feedback

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

INCA feedback

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Usual Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean rate of actual Adherence to preventer medication

Description

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.

Time Frame

week 20 through 32

Title

The between-group difference in the proportion of patients prescribed guideline appropriate medication at the end of the study.

Description

Time Frame

week 20 through 32

Secondary Outcome Measure Information:

Title

Cost-effectiveness and economic evaluation of the INCA educational intervention

Description

Time Frame

First 8 weeks of the study and week 20 to 32

Title

Change in Asthma Control Test scores at week 32

Description

ACT scores will be obtained during the study visits.

Time Frame

Baseline to week 32

Title

Change in PEF variability

Description

Differences between the two study groups will be calculated

Time Frame

Baseline to week 32

Title

Change in AQLQ

Description

AQLQ scores will be obtained during the study visits.

Time Frame

Baseline to week 32

Title

Exacerbations over study period

Description

It is hypothesised that with active education, exacerbation frequency can be reduced.

Time Frame

Baseline to week 32

Title

To compare the proportion of patients who were clinically stable

Description

The proportion of patients who required no daily reliever use in the month prior to study end will be compared.

Time Frame

First 8 weeks of the study and week 20 to 32

Title

Relationship of biomarkers with adherence

Description

Time Frame

Baseline to week 32

Title

The proportion of patients who are refractory to treatment

Description

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.

Time Frame

First 8 weeks of the study and week 20 to 32

Title

The proportion of patients who are non-adherent and remain uncontrolled

Description

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.

Time Frame

First 8 weeks of the study and week 20 to 32

Title

The proportion of patients with inhaler related side effects

Description

The proportion of patients with inhaler related side effects including oral candidiasis between the active and control groups will be compared.

Time Frame

First 8 weeks of the study and week 20 to 32

Other Pre-specified Outcome Measures:

Title

Patient identified goal

Description

Proportion of patients reaching stated clinical goal at week 12 and between that period and week 32.

Time Frame

Baseline to week 32

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elaine MacHale, RN MSC

emachale@rcsi.ie

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard w Costello, MD

Organizational Affiliation

RCSI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beaumont Hospital

City

Dublin

ZIP/Postal Code

Country

Ireland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elaine MacHale, RN MSc

emachale@rcsi.ie

First Name & Middle Initial & Last Name & Degree

Lorna Lombard, RN

lornalombard@rcsi.ie

First Name & Middle Initial & Last Name & Degree

Richard Costello, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

28619778

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.

Results Reference

background

PubMed Identifier

33369570

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.

Results Reference

derived

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Inhaler Adherence in Severe Unstable Asthma

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