COMPARATIVE EFFECTIVENESS AND SAFETY OF BUDESONIDE STERINEBS® VS. PULMICORT RESPULES® IN A US POPULATION OF ASTHMA PATIENTS.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26273
• EU PAS number:
  EUPAS7678
• Study ID:
  26273
• Official title and acronym:
  COMPARATIVE EFFECTIVENESS AND SAFETY OF BUDESONIDE STERINEBS® VS. PULMICORT RESPULES® IN A US POPULATION OF ASTHMA PATIENTS.
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Historic cohort, US database study comparing effectiveness and safety of nebulised medication labelled by TEVA Ltd (Budesonide SteriNebs®) against the originator product (Pulmicort Respules®), in patients with a diagnosis for asthma.
• Study status:
  Finalised

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: 07/07/2014

Data analysis start date

Planned: 15/08/2014

Actual: 22/08/2014

Date of interim report, if expected

Planned: 26/09/2014

Actual: 26/09/2014

Date of final study report

Planned: 03/11/2014

Actual: 31/10/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

TEVA Ltd

Study protocol

Initial protocol

R04913_Budesonide Sterinebs_Protocol v04

Regulatory

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