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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-Interventional, post-authorization efficacy study

Population studied

• Short description of the study population:
  Adult patients of either sexes with diagnosis of asthma, treated with novel combination therapy of budesonide/formoterol fumarate (BUFOMIX EASYHALER® 160 / 4.5 micrograms or 320 / 9.0 micrograms) at least 14 days before enrollment into the study in Poland by 250 allergist and pulmonologist or doctors currently in course of obtaining these specializations.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  2500

Study design details

• Main study objective:
  the assessment of the efficacy of BUFOMIX EASYHALER® (budesonide/formoterol fumarate 160/4.5 micrograms or 320/9.0 micrograms dose inhalation) in the form of powder for inhalation in patients with asthma.
• Data analysis plan:
  The Study Questionnaires (SQ) will be transferred from the Study centers to the Office of the Study Organizer will be analyzed in terms of completeness, consistency, clarity and compliance with the Protocol. If data elements are missing from the SQ, the Investigator should state the reason for the missing data or other deviations from the Protocol. The Office of the Study Organizer will communicate to the Investigator any questions regarding the processing of data and the points that have not been sufficiently explained, for the purpose of clarification or improvement. The Investigator must ensure that all requests for clarification of data are immediately addressed. TheInvestigator is obliged to keep copies of all data, including a record of all changes and clarifications with SQ. Epidemiological and Statistical analysis of the data will be carried out in accordance with the standards of the EU GCP/ICH.

Documents

Study results

Budesonide Publication

Study publications

Pirożyński M, Hantulik P, Almgren-Rachtan A, Chudek J. Evaluation of the effici…