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Inhaler Adherence in Severe Unstable Asthma (INCA-SUN)

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ClinicalTrials.gov Identifier: NCT02307669
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Richard Costello, Beaumont Hospital

Brief Summary:

The investigators hypothesize that aligning 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 assess inhaler adherence and relates adherence with changes in PEFR and symptom scores over time.

The aim of the study is to then incorporate adherence into Guideline recommended medication changes so that asthma control is improved and medication rationalised at the end of the intervention.

A secondary aim is to assess the long-term effectiveness of this approach on control and exacerbations.


Condition or disease Intervention/treatment Phase
Asthma Behavioral: INCA feedback Not Applicable

Detailed Description:

The investigators hypothesize that aligning adherence with the patient's own clinical course achieves better asthma control and allows physicians to identify risks for future loss of control, compared to current best practice.

The investigators will compare two asthma education interventions, standard Guideline recommended practice and feedback from the individual's own INCA device, which assess inhaler adherence and relates adherence with changes in PEFR and symptom scores over time.

The aim of the study is to improve and maintain adherence to preventor therapy, so that medication and other costs as well as quality of life, exacerbation rates are optimal.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A Study on Inhaler Adherence to Improve Poor Asthma Control
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Routine inhaler adherence care

Normal Care group This management is based on the recommendations of the BTS/SIGN group (http://www.brit-thoracic.org.uk/Portals/0/Guidelines/AsthmaGuidelines/sign101%20Jan%202012.pdf)

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 PEFR and symptoms will be given.
  4. In follow up, medication changes in response to the above will be directed by these, as suggested by Guidelines
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.

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 hand held PEFR and AQLQ are correlated with the 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, PEFR, ACT and exacerbations) will be made
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.




Primary Outcome Measures :
  1. 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.

  2. Proportion of necessary step up therapy prescriptions (monoclonal antibody), calculated by looking at the INCA device data and determining whether the step-up therapy was necessary. [ Time Frame: week 20 through 32 ]
    This study will focus on severe asthma patients, who remain uncontrolled and Incorporating adherence into Guideline suggested decision making may reduce unnecessary prescribing. Medication cost, as well as Hospital and emergency care costs between the active and control group will be compared.


Secondary Outcome Measures :
  1. 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.


  2. Change in the 25 point Asthma Control Test scores at 32 week [ Time Frame: Week 8 to 32 ]
    ACT scores will be obtained during the study visits.

  3. Change in PEFR variability from week 20 through 32 [ Time Frame: Week 8 to 32 ]
    Variability will be measured by detrended fluctuation analysis and by means on control charts.

  4. Change in AQLQ from week 20 through 32 [ Time Frame: Week 8 to 32 ]
    AQLQ scores will be obtained during the study visits.

  5. Exacerbations over study period [ Time Frame: Week 8 to 32 ]
    It is hypothesised that with active education, exacerbation frequency can be reduced.

  6. 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.

  7. Relationship of biomarkers with adherence [ Time Frame: First 8 weeks of the study and week 20 to 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.

  8. 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 exacerbations, PEFR am/pm <80% and ACT ≤19) will be conducted.

  9. 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%, PEFR am/pm <80% and ACT≤19) between the active and control groups will be compared.

  10. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be willing to give voluntary informed consent
  • Must have a clinical diagnosis of asthma-
  • Must have a bronchodilator FEV1 > 40% and <80% in the past 1 year
  • Current unstable asthma i.e. ACT score is less than 19 at enrolment.
  • 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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307669


Contacts
Contact: Elaine MacHale, RN MSC emachale@rcsi.ie

Locations
Ireland
Beaumont Hospital Recruiting
Dublin, Ireland, 9
Contact: Elaine MacHale, RN MSc       emachale@rcsi.ie   
Contact: Carole Schilling, RN       cschilling@rcsi.ie   
Principal Investigator: Richard Costello, MD         
Sponsors and Collaborators
Beaumont Hospital
Investigators
Principal Investigator: Richard w Costello, MD RCSI

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Richard Costello, Professor of Medicine, Beaumont Hospital
ClinicalTrials.gov Identifier: NCT02307669     History of Changes
Other Study ID Numbers: INCA-Sun
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases