Comparative effectiveness and safety of Salbutamol Sterinebs® vs Ventolin Nebules® in COPD patients.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26285
• EU PAS number:
  EUPAS7645
• Study ID:
  26285
• Official title and acronym:
  Comparative effectiveness and safety of Salbutamol Sterinebs® vs Ventolin Nebules® in COPD patients.
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Historic cohort, UK database study comparing effectiveness and safety of nebulised medication labelled by TEVA Ltd (Salbutamol SteriNebs®) against the originator product (Ventolin Nebules®), in patients who received a diagnosis for COPD
• Study status:
  Ongoing

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 07/05/2014

Actual: 07/05/2014

Study start date

Planned: 30/06/2014

Actual: 30/06/2014

Data analysis start date

Planned: 15/08/2014

Actual: 19/08/2014

Date of interim report, if expected

Planned: 26/09/2014

Actual: 26/09/2014

Date of final study report

Planned: 03/11/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

TEVA Ltd

Regulatory

• Was the study required by a regulatory body?:
  Unknown
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable