Study identification

PURI

https://redirect.ema.europa.eu/resource/34422

EU PAS number

EUPAS31405

Study ID

34422

Official title and acronym

A pragmatic, cluster randomized trial evaluating the impact of an enhanced adherence package (dual bronchodilator+add-on+app) on time to treatment failure and other clinical outcomes in exacerbating COPD patients with poor adherence to mono or dual therapy over one year (MAGNIFY)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Not taking medications as prescribed is an issue affecting patients irrespective of disease and treatment type and can lead to poor clinical outcomes such as worsening symptoms. In COPD, guidelines have noted the importance of supporting patients with their regular inhaler use as part of COPD management.This study (MAGNIFY) will enable randomly selected GP practices to support COPD inhaler use in their patients through a new technology by Propeller Health (US). This technology includes a device which is attached to the Ultibro® inhaler, monitors inhalations and sends reminders to the user’s smartphone to take their daily dose. As part of this research, the device can be offered to suitable patients for 12 months. At theend of the study, researchers will assess the impact of the technology on clinical outcomes such as COPD exacerbations and medication use. Outside this research, the technology is currently available to healthcare providers in the UK through programs with Propeller Health with a range of inhalers.The study aims to recruit 176 GP practices in the UK and collect non-identifiable data from 2624 people. Halfof the participating GP practices will be randomly selected to receive access to the technology. The other GP practices will continue their usual patient care.The study does not involve any visits outside usual care. Data will be extracted from the participating GP practices’ routine medical records at each site at the beginning of the study and regularly until the end of the study. All data will be stored in an ethically approved Optimum Patient Care Research Database (https://opcrd.co.uk). Any data shared with the researchers will be fully de-identified.

Study status

Planned
Research institutions and networks

Institutions

Networks

Contact details

Rupert Jones

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Other
Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG, OPRI Pte Ltd
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable