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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beaumont Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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