Study identification

PURI

https://redirect.ema.europa.eu/resource/27569

EU PAS number

EUPAS9651

Study ID

27569

Official title and acronym

CRITIKAL Study

DARWIN EU® study

No

Study countries

Australia
France
Italy
Netherlands
Norway
Spain
United Kingdom

Study description

To assess the association between patient/treatment factors, including inhaler technique, lung function and comorbidities and asthma control in patients receiving fixed dose combination therapy (FDC), inhaled corticosteroids/long-acting beta agonists (ICS/LABA), ± short-acting beta2-agonist (SABA) therapy.A further aim will be to identify errors in inhalation technique that constitute ‘critical errors’ defined as those that have an adverse effect on asthma control.

Study status

Finalised
Research institution and networks

Institutions

Contact details

David Price

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

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

More details on funding

Mundiphama, Teva, Rirl
Study protocol
Initial protocol

Critikal Study_Protocol_31032015_V5.4

English (1.39 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable