ASSESSMENT OF THE EFFICACY OF COMBINATION THERAPY BUDESONIDE/FORMOTEROL FUMARATE (BUFOMIX EASYHALER 160/4.5 µG OR 320/9.0 µG PER INHALATION) IN PATIENTS DIAGNOSED WITH ASTHMA (ORN/AST/2016/004)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22949
• EU PAS number:
  EUPAS16451
• Study ID:
  22949
• Official title and acronym:
  ASSESSMENT OF THE EFFICACY OF COMBINATION THERAPY BUDESONIDE/FORMOTEROL FUMARATE (BUFOMIX EASYHALER 160/4.5 µG OR 320/9.0 µG PER INHALATION) IN PATIENTS DIAGNOSED WITH ASTHMA (ORN/AST/2016/004)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  This is a prospective non-interventional observational study of aproximately 2500 patients in Polish population receiving combination therapy bufomixeasyhaler - inhalation powder containing budesonide/formoterol fumarate - 160/4.5 µg or 320/9.0 µg per inhalation active substances for at least 14 days prior to study enrollment. All study participants will be followed-up for at least 6 months. Data on the efficacy BUFOMIX EASYHALER formulation will be recorded in a Study Questionnaire (SQ) over three consecutive visits (planned according to the rutine clinical needs of the patient), within a period of 6 months from the initiation of the use of BUFOMIX EASYHALER. The efficacy will be assessed on the basis of ACT scale and the results of spirometry and compliance on the basis of the Medication Adherence Questionnaire (MAQ).The role of the study is to establish that new combination therapy budesonide/formoterol fumarate (bufomixeasyhaler 160/4.5 µg or 320/9.0 µg) is efficient and safe in treatment of patients diagnosed with asthma. Non additional diagnostic procedures or monitoring will be used, and all data will be collect during the rutine use of BUFOMIX EASYHALER. Analisis of the collected data will be preformed by epidemiological methods only.
• Study status:
  Finalised

Research institutions and networks

Institutions

Europharma

Study timelines

Date when funding contract was signed

Planned: 08/03/2016

Actual: 08/06/2016

Study start date

Planned: 15/04/2016

Actual: 15/06/2016

Data analysis start date

Planned: 15/12/2016

Actual: 13/12/2016

Date of final study report

Planned: 31/05/2017

Actual: 26/04/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Orion Pharma Poland Sp. z o.o.

Study protocol

Initial protocol

ORN-2016-AST PB

Regulatory

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