A real-life historic study assessing metabolic and other adverse effects of small versus large particle inhaled corticosteroids in relation to their clinical benefit in obstructive lung disease

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/10959
• EU PAS number:
  EUPAS8832
• Study ID:
  10959
• Official title and acronym:
  A real-life historic study assessing metabolic and other adverse effects of small versus large particle inhaled corticosteroids in relation to their clinical benefit in obstructive lung disease
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Aims to compare metabolic and other adverse effects of small (QVAR and Ciclesonide) vs. large particle (FP and Clenil) ICS in patients initiating and stepping-up their ICS therapy, and comparing results to appropriate control groups. The primary outcomes are:Diagnosis of pneumonia Diagnosis of pneumonia confirmed by chest x-ray or resulting in hospitalisation within one month of diagnosisFirst diagnosis of type 2 diabetes and/or prescription for anti-diabetic medication Progression of ongoing type 2 diabetes treatment to insulinChange in anti-diabetic medication Change in HbA1c valueChange in BMI
• Study status:
  Finalised

Research institution and networks

Institutions

Research in Real Life

Study timelines

Date when funding contract was signed

Actual: 01/02/2013

Study start date

Actual: 01/11/2013

Data analysis start date

Actual: 03/02/2014

Date of final study report

Planned: 01/06/2015

Actual: 29/04/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva

Regulatory

• Was the study required by a regulatory body?:
  No