Study identification

PURI

https://redirect.ema.europa.eu/resource/8392

EU PAS number

EUPAS8391

Study ID

8392

Official title and acronym

Real-world effectiveness of extrafine vesrus standard particle inhaled corticosteroids: A comparative effectiveness analysis of extrafine (EF) hydrofluoroalkane beclometasone (HFA-BDP) and Ciclesonide versus commonly prescribed standard particle inhaled corticosteroids for patients prescribed asthma therapy in The Netherlands (Extrafine vesrus stand particle ICS effectiveness)

DARWIN EU® study

No

Study countries

Netherlands

Study description

Project Description: To compare the effectiveness (in terms of exacerbation prevention and asthma control) of extra-fine vs standard particle ICS in asthma patients initiating or stepping-up ICS therapy in the NetherlandsPatient population: patients receiving asthma therapy other than ICS (adult and paediatric) and initiating ICS therapy as either extra-fine particle ICS (QVAR + Ciclesonide) or standard particle ICS (FP + non-EF-BDP)Data source: Pharmacy and hospital records from the PHARMO Database Network (The Netherlands)

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Cristiana Miglio

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
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Data analysis start date

Planned:
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Date of interim report, if expected

Planned:
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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Teva
Study protocol
Initial protocol

R02911_PHARMO main study_study protocol_for registration

English (346.15 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No