Inhaler Adherence in Severe Unstable Asthma

NCT02307669 | Unknown DMC

• 1 other identifier: INCA-Sun
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Adherence; Inhaler; GINA

Outcome Measures

Primary Outcomes (2)

• 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.

  week 20 through 32

• 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

  week 20 through 32

Secondary Outcomes (10)

• Cost-effectiveness and economic evaluation of the INCA educational intervention

  First 8 weeks of the study and week 20 to 32

• Change in Asthma Control Test scores at week 32

  Baseline to week 32

• Change in PEF variability

  Baseline to week 32

• Change in AQLQ

  Baseline to week 32

• Exacerbations over study period

  Baseline to week 32

Other Outcomes (1)

• Patient identified goal

  Baseline to week 32

Study Arms (2)

Routine inhaler adherence care

PLACEBO COMPARATOR

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

INCA feedback

ACTIVE COMPARATOR

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

Interventions

INCA feedback BEHAVIORAL

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.

INCA feedback

Usual Care BEHAVIORAL

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.

Routine inhaler adherence care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beaumont Hospital: lead

Study Sites (1)

Beaumont Hospital

Dublin, 9, Ireland

RECRUITING

Related Publications (3)

• 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.

  PMID: 28619778 BACKGROUND

• Hale EM, Greene G, Mulvey C, Mokoka MC, van Boven JFM, Cushen B, Sulaiman I, Brennan V, Lombard L, Walsh J, Plunkett S, McCartan TA, Kerr PJ, Reilly RB, Hughes C, Kent BD, Jackson DJ, Butler M, Counihan I, Hayes J, Faul J, Kelly M, Convery R, Nanzer AM, Fitzgerald JM, Murphy DM, Heaney LG, Costello RW; INCA Research Team. Use of digital measurement of medication adherence and lung function to guide the management of uncontrolled asthma (INCA Sun): a multicentre, single-blinded, randomised clinical trial. Lancet Respir Med. 2023 Jul;11(7):591-601. doi: 10.1016/S2213-2600(22)00534-3. Epub 2023 Mar 21.

  PMID: 36963417 DERIVED

• 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.

  PMID: 33369570 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Richard w Costello, MD

  RCSI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine MacHale, RN MSC

CONTACT

emachale@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: December 4, 2014
• Study Start: December 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: December 31, 2020
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

IE (1)