Real-world effectiveness of extra-fine Ciclesonide (Alvesco®) versus standard particle inhaled corticosteroid (ICS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Alvesco
• Anatomical Therapeutic Chemical (ATC) code:
  (R01AD) Corticosteroids

  Corticosteroids
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Asthma patients aged 12-60 years with a history of ≥2 prescriptions for asthma therapy and initiating inhaled corticosteroid (ICS) treatment as extra-fine (EF)-ICS ciclesonide or standard particle (SP)-ICS who have at least one full year of baseline data (prior to the prescription date) and at least one full year of outcome data.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  4064

Study design details

• Main study objective:
  To compare effectiveness (in terms of asthma control) of extra-fine ICS Ciclesonide (Alvesco) vs standard particle ICS
• Outcomes:
  (i) Asthma Exacerbation Rate:• Asthma related hospital admissions OR• Use of acute oral steroid .(ii) Risk domain asthma control:• Hospital attendance/admission, AND• Prescriptions for acute courses of oral steroids.(iii) Overall asthma control:• Risk domain asthma control AND• Average daily dose of ≤200mcg salbutamol / ≤500mcg terbutaline, (i) Change in therapy :- Addition of new therapy, including LTRA, THEO or LABA OR, - Patients who increased their ICS therapy by ≥50%.(ii) Average daily short-acting β2-agonists (SABA) usage during outcome year, calculated as average number of puffs per day over the year multiplied by strength.
• Data analysis plan:
  Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and by therapy. Treatment groups will be compared using t-test / Mann Whitney U-test (depending on distribution) for variables measured on the interval/ratio scale and using a chi square test for categorical variables.Outcomes analyses: patients will be matched on demographics and key measures ofdisease severity to ensure comparison of similar patients, using random selection process through SASstatistical software to avoid selection bias.Effectiveness outcomes will be compared between treatment groups using a conditional regression model. The model will use empirical standard errors (for more conservative confidence interval estimations) and adjustments will be made for potential baseline confounders. The adjusted rate ratio with 95% confidence interval will be reported.