A real-life historic study assessing metabolic and other adverse effects of small versus large particle inhaled corticosteroids in relation to their clinical benefit in obstructive lung disease

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Metabolic events evaluation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FLUTICASONE PROPIONATE

  CICLESONIDE

  BECLOMETASONE DIPROPIONATE
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

  Pneumonia

  Diabetes mellitus

Population studied

• Short description of the study population:
  Obstructive lung disease patients initiating and stepping-up their Inhaled corticosteroids (ICS) therapy.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  Compare for large particle vs small particle ICS:Diagnosis of pneumonia First diagnosis of type 2 diabetes and/or prescription for anti-diabetic medication Progression of ongoing type 2 diabetes treatment to insulinChange in anti-diabetic medication (e.g. type or dose prescribed) Change in HbA1c valueChange in BMI
• Outcomes:
  Co-primary outcomes:(i) First diagnosis of diabetes and/or prescription for anti-diabetic medication (ii) Progression of ongoing diabetes treatment to insulin(iii) Change in HbA1c value(iv) Change in anti-diabetic medication (e.g. type or dose prescribed) (v) Change in BMI (vi) Diagnosis of pneumonia (vii) Exacerbation of obstructive lung disease
• Data analysis plan:
  Treatment arms will be compared using (conditional) logistic regression, Poisson regression and Cox regression.