Our Main Randomised Control Trial is the
INCA SUN STUDY
Principal Investigator - Professor Richard Costello
INhaler Compliance Assessment Device in Symptomatic Uncontrolled Asthma - INCA Sun study will compare the outcomes of two groups of patients with severe asthma. One group will be randomised to receive feedback education on their inhaler use, using INCA Technology along with electronically recorded peakflow data. The second group of patients will continue to use their inhalers and receive guideline recommended asthma education and clinical monitoring.
220 Patients will be recruited from severe asthma clinics in Ireland including: Beaumont Hospital, Belfast City Hospital, St. Vincent’s Hospital, Connolly Hospital and Cork University Hospital.
On conclusion we believe that information provided from the INCA technology along with electronically recorded peakflow data & environmental data can be integrated and used to guide both asthma nurse training and physician management better than current standard care.
Currently Open for Recruitment
Contact our Research Nurses on: 01-8093787 or Email inca@rcsi.ie
WWW.CLINICALTRIALS.GOV; NCT02307669
INCA R-ACE
Risk Factors for RE-exacerbation after a chronic obstructive pulmonary disease (copd) exacerbation
Principal Investigator - Professor Richard Costello
This study explores why some patients experience a re-exacerbation, focusing particularly on changing lung volumes during recovery.
Exacerbation's of COPD hasten lung function (FEV1) decline and patient mortality. One-third of patients are re-hospitalised within 90 days. Persistent hyperinflation on discharge may be implicated.
INCA R-ACE measures pulmonary function, symptoms and gait speed at multiple time points during a hospital admission. Baseline demographics, social and medical history are recorded. Quality of inpatient hospital care is determined. Patients are re-assessed at day 30 and 90 and any new exacerbation's are recorded.
250 Patients from Beaumont Hospital & St. Vincent's University Hospital Dublin who are hospitalised with a COPD exacerbation will be recruited.
On conclusion, we hope to identify a physiological marker that will determine re-exacerbation risk and will aid physicians in determining when a patient is suitable for discharge with a low risk of re-exacerbation.
Currently Open for Recruitment
www.clinicaltrials.gov; NCT02644772
INCA DELIVER
Determining Errors in Leading Inhalers and Validating the ERrors (Validation Study Part 2)
Principal Investigator - Professor Richard Costello
The INCA DELIVER Study is an EI Grant Funded Study, involving a three way partnership between RCSI, Trinity College Dublin and Vitalogrpah LTD. The project focus' is on the development of an INCA-like technology for four new inhaler devices and developing a validated process for the development of such algorithms. The benefit associated with the development of new devices will be for their potential use in clinical practice to improve healthcare decisions and reduce the cost of treating the patient.
The new technology could also be a key feature in increasing clinical trial success as patients could be provided with the newly adapted inhalers to account for and correct poor adherence to medication.
15 healthy volunteers from RCSI & Beaumont Hospital will be recruited.
On conclusion, among other objectives, we aim to identify common inhaler technique errors and establish whether there is a relationship between common inhaler technique errors, the volume inhaled and the amount of drug delivered to the body.
Currently Open for Recruitment
INCA COPD
Adherence to Inhaled Therapy and Clinical Outcomes in Chronic Obstructive Pulmonary Disease (COPD)
Principal Investigator - Professor Richard Costello
Re-exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are significant and common events in the clinical course of the disease and result in poorer clinical outcomes. The impact of medication adherence in a real-world setting on re-exacerbation events will be assessed.
Baseline demographics, symptom scores and medical history are recorded at the time of recruitment. In addition patients complete European Healthy Literacy Questionnaire, Montreal Cognitive Assessment and Belief in Medicines Questionnaire. Patients are contacted monthly for 3 months and any exacerbations or hospitalisations within that time period were documented.
246 patients who were hospitalised with an acute exacerbation of COPD were recruited. On discharge, all patients are provided with an inhaler with an INCA (electronic recording) device attached. Using the INCA technology intentional and non-intentional non-adherence is calculated.
On conclusion, we hope to determine the relationship between medication adherence and health-related outcomes, and to assess whether an individual's pattern of adherence can be used to predict the onset of an exacerbation.
This study has finished recruitment.
another area of specialist interest is in exacerbation prediction
Prediction Modelling Study
Principal Investigator - Professor Richard Costello
The INCA Team are involved in a HRB funded project called the Prediction Modelling Study. The aim of this study is to examine why 10 per cent of people with asthma, are unable to control their symptoms using their inhalers.
The principal research interest is the exploration of the relationship between adherence, lung function and the affect of environmental factors. This research project aims to develop an exacerbation risk tool that incorporates knowledge of adherence with changes in environmental factors that trigger exacerbations along with personal and disease specific characteristics. This tool could be used by both patients and clinicians to monitor lung function and warn off impending asthma attacks.