Study identification

EU PAS number

EUPAS16395

Study ID

34038

Official title and acronym

An Open-label Observational Safety Study of Colobreathe® (colistimethate sodium dry powder for inhalation) Compared with Other Inhaled Anti-pseudomonal Antibiotics in Cystic Fibrosis Patients Using Cystic Fibrosis Registries

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This observational, registry-based safety study is being conducted pursuant to a post-authorisation commitment with EMA. The study has been designed to evaluate the long-term safety of Colobreathe used in patients with cystic fibrosis with P. aeruginosa infection of the lungs, compared with other inhaled anti-pseudomonal antibiotics. Particular attention will be paid to adverse events (AEs) of cough/productive cough, chest discomfort/chest pain, wheezing/bronchospasm, dyspnoea, dysphonia, lower respiratory tract infection, and taste abnormality (dysgeusia) occurring in the first 90 days of treatment. The study population includes patients enrolled in the UK cystic fibrosis (CF) registry database who are prescribed Colobreathe (treated group) versus matched patients in the CF registry database not treated with Colobreathe but taking other inhaled antibiotic treatments (Comparator-treated). Patients prescribed Colobreathe and matched patients receiving other inhaled antibiotic therapies will be followed-up for up to 5 years.

Study status

Finalised
Research institutions and networks

Institutions

Cystic Fibrosis Trust
United Kingdom
First published:
01/02/2024
Institution Not-for-profit

Contact details

Diana Bilton

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

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

More details on funding

Teva
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)