Real-world effectiveness of extra-fine Ciclesonide (Alvesco®) versus standard particle inhaled corticosteroid (ICS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25917
• EU PAS number:
  EUPAS6147
• Study ID:
  25917
• Official title and acronym:
  Real-world effectiveness of extra-fine Ciclesonide (Alvesco®) versus standard particle inhaled corticosteroid (ICS)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  Aim of the study:A retrospective, database analysis comparing effectiveness (in terms of exacerbations prevention and asthma control) of Ciclesonide, an extra-fine (EF) particle ICS, with other commonly prescribed standard particle (SP) ICS therapies in patients prescribed asthma therapy from the Netherlands.Data source: the PHARMO Database Network, comprising pharmacy and hospital discharge records for approximately 20% of the Dutch population. Study population: The study population will include patients aged 12-60 years with a history of ≥2 prescriptions for asthma therapy and initiating ICS treatment as EF-ICS ciclesonide or SP-ICS. Data will be collected over one year before (baseline) and one year after (outcome) treatment initiation. Study period is September 2005 – December 2012. Potential COPD patients (>60 years old and those using long-acting muscarinic antagonists) will be excluded.Primary outcomes: Severe exacerbation rate in the year after initiation of ICS therapy, defined as asthma-related hospital admissions OR use of acute oral steroids (based on the American Thoracic Society/European Respiratory Society task force definition).Modified definition of Risk Domain Asthma Control in the year after initiation of ICS therapy, defined as absence of asthma-related hospital admissions AND absence of prescriptions for acute courses of oral steroids.Modified definition of Overall Asthma Control in the year after initiation of ICS therapy defined as no asthma-related hospital admissions AND no prescriptions for acute courses of oral steroids AND average daily dose of ≤200mcg salbutamol / ≤500mcg terbutaline.
• Study status:
  Finalised

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

OPRI Pte Ltd

Multiple centres: 2 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 31/03/2014

Actual: 18/06/2014

Study start date

Planned: 01/04/2014

Actual: 01/04/2014

Data analysis start date

Planned: 22/05/2014

Actual: 22/05/2014

Date of final study report

Planned: 22/12/2014

Actual: 22/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Pharmaceuticals

Study protocol

Initial protocol

R00114_Ciclesonide Study Protocol_registered_241214

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable