Study identification

PURI

https://redirect.ema.europa.eu/resource/48244

EU PAS number

EUPAS10376

Study ID

48244

Official title and acronym

PRJ2282/201491: CHESS: CPRD-COPD Hawthorne Effect Study in Salford: A UK cohort study to characterise patients enrolled in the Salford Lung Study and to evaluate a potential Hawthorne effect

DARWIN EU® study

No

Study countries

United Kingdom

Study description

The Salford Lung Study (SLS) is a unique Phase IIIB pragmatic trial evaluating the effectiveness of a novel medicine – RELVAR – compared with standard of care (SOC) among patients with Chronic Obstructive Pulmonary Disease (COPD). The trial is taking place in Salford, England. While the pragmatic nature of the trial is designed to test effectiveness in routine care, there are at least two possible concerns: 1) Salford may not be representative of the wider population in which the medicine may be used, and 2) there may be differences in local practice or changes to local practice caused by the study (the Hawthorne effect), which may artificially inflate the benefits of both RELVAR and SOC. The aim of this study (CHESS) is to evaluate the representativeness of Salford, and the potential Hawthorne effect to place the SLS in wider context.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Sperrin Matthew

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

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

More details on funding

GSK
Study protocol
Initial protocol

CHESS_Proposal_PRJ2282_FINAL

English (909.57 KB - PDF)View document
Updated protocol

gsk-201491-protocol-redact-v02

English (9.9 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Non-EU RMP only