Comparative effectiveness and safety of Ipramol (ipratropium/albuterol) SteriNebs® vs. DuoNeb®

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/9095
• EU PAS number:
  EUPAS7753
• Study ID:
  9095
• Official title and acronym:
  Comparative effectiveness and safety of Ipramol (ipratropium/albuterol) SteriNebs® vs. DuoNeb®
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Historic cohort, US database study comparing effectiveness and safety of nebulised COPD medication labelled by Teva Ltd (Ipramol SteriNebs®) against the originator product (DuoNeb®)
• Study status:
  Finalised

Research institutions and networks

Institutions

Research in Real Life

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: 19/09/2014

Date of interim report, if expected

Planned: 14/10/2014

Actual: 14/10/2014

Date of final study report

Planned: 03/11/2014

Actual: 03/11/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva

Study protocol

Initial protocol

R05113_Ipramol_Sterinebs_Protocol_V03

Regulatory

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