Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000403

EU PAS number

EUPAS1000000403

Study ID

1000000403

Official title and acronym

DARWIN EU® -Drug utilisation of salbutamol products for inhalation and therapeutic alternative inhalation products

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Germany
Netherlands
Spain
United Kingdom

Study description

Salbutamol is essential for managing asthma and chronic obstructive pulmonary disease (COPD) due to its rapid bronchodilation effects. The rising prevalence of these conditions in Europe, driven by aging populations and worsening air quality, has led to increased demand for salbutamol, especially in urban areas. A shortage would severely impact patient care, leading to challenges in managing acute symptoms and increased strain on alternative therapies, which are not as effective for immediate relief.
The aim of the study is to understand if salbutamol (inhaled formulation) use has been increasing over the last few years in Europe which will in turn inform a potential risk of shortage. And secondly to understand the impact of the shortage of salbutamol inhaled formulations on therapeutic alternative inhalation products. This exercise falls under preparedness and prevention activities.

Study status

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Marzyeh Amini

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
EMA
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C1-016_DUS_Salbutamol_V3.pdf

English (787.64 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable