Study identification

PURI

https://redirect.ema.europa.eu/resource/27095

EU PAS number

EUPAS12292

Study ID

27095

Official title and acronym

A long term prospective observational study of the safety and tolerability of Bramitob® administered twice daily over three 28-day “on”/28-day “off” cycles to patients with cystic fibrosis having severely compromised lung function (Bethkis study)

DARWIN EU® study

No

Study countries

Austria
Hungary
Ireland
Italy
Slovakia

Study description

This will be a long-term observational, non-interventional, multi-center study in approximately 30 Bramitob-exposed patients and 30 TOBI-exposed patients who meet all inclusion/exclusion criteria, e.g., have a stable baseline FEV1 ≥25% and <40% predicted and are not candidates for lung transplantation.The study will be conducted via a medical chart review in a prospective fashion. Due to the study’s observational nature, the decision to treat with Bramitob® or TOBI®, the medical care given to patients, and the monitoring and assessments of the patients will not be scripted. Data obtained during routine clinic visits occurring during the observational period will be collected via a medical chart review and will be used to evaluate efficacy, safety, and tolerability. The end of the trial is defined as the last visit recorded after completion of three nebulized tobramycin inhalation solution treatment cycles of the last patient included in the study.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Guido Varoli

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Chiesi Farmaceutici S.p.A.
Regulatory

Was the study required by a regulatory body?

Yes

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

Non-EU RMP only