INCA SUN
Research type
Research Study
Full title
Inhaler Compliance Assessment (Asthma) INCA SUN: A Prospective 12 month, randomised, controlled, multicentre asthma education study in patients with unstable asthma using the INCA device
IRAS ID
172824
Contact name
Liam Heaney
Sponsor organisation
Royal College of Surgeons Ireland
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
European Clinical Trials Database (EurdraCT), 2011-004149-42
Duration of Study in the UK
1 years, 6 months, 24 days
Research summary
Research Summary:
This is a prospective, multicentre, randomised, parallel design, 32 week trial of patients with poorly controlled asthma who are at Step 3 to 5 GINA guideline therapy treated at specialist asthma clinics. Approximately 220 subjects, 110 subjects per treatment arm, over a 2 year period will be recruited and randomised 1:1 ratio with equal chance into two treatment arms; Inhaled Compliance Assessment (INCA) directed feedback or guideline suggested care. The study will compare the outcomes of patients with severe asthma randomised to receive feedback education on their use of salmeterol/fluticasone, beta agonist reliever use PEFR data with compared to those who continue to use salmeterol/fluticasone and receive guideline recommended asthma education and clinical monitoring. The feedback and education will be be given by the PhD student. Researchers in the Royal College of Surgeons in Ireland and Trinity College Dublin developed a small device that is attached to a Seretide Diskus inhaler. The device called INCA (Inhaler Compliance Assessment). It electronically records the timing and inhaler technique when the diskus is used. Information on a microchip in the device allows both the doctor and the patient to track how the inhaler is being used. The aim of this study is to find out if the use of this device can lead to better improved technique and usage of their inhaler and improved asthma control for patients.Summary of Results:
In the INCA sun study, we set out to address if the accuracy of management of severe asthma could be improved by accurately assessing medication adherence, in particular among patients with severe asthma who were being considered for an add-on biologic therapy.REC name
HSC REC B
REC reference
16/NI/0038
Date of REC Opinion
19 Apr 2016
REC opinion
Further Information Favourable Opinion