A long term prospective observational study of the safety and tolerability of Bramitob® administered twice daily over three 28-day “on”/28-day “off” cycles to patients with cystic fibrosis having severely compromised lung function (Bethkis study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Safety and tolerability of Bramitob

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  prospective, observational study

Study drug and medical condition

• Medicinal product name, other:
  Bramitob
• Medical condition to be studied:
  Cystic fibrosis lung

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  To describe the following in patients suffering from CF and receiving Bramitob®, who have severely compromised pulmonary function:• Risk of upper airway and bronchial hypersensitivity/irritation, • Efficacy in terms of FEV1, pulmonary exacerbations, anti-pseudomonal use, hospitalizations and death.
• Outcomes:
  Efficacy Variables• FEV1 (expressed as liters and % predicted), • Number of pulmonary exacerbations as defined by Fuchs,• Anti-pseudomonal use, • Number of planned and unplanned hospitalizations,• Death.Safety Variables• AEs and ADRs, • AEs of special interest which will be queried for will include: acute, decreases in FEV1, bronchospasm, wheezing, dyspnea, cough, hemoptysis
• Data analysis plan:
  Descriptive analysis of efficacy and safety variables