Observational Program to Study Prescribing Practices of Montelast, 10 mg Film-coated Tablets (manufactured by Actavis Ltd., Malta for Actavis Group PTC ehf., Iceland) For Treatment of Bronchial Asthma and Allergic Rhinitis

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Name of medicine, other:
  Montelast
• Medical condition to be studied:
  Asthma

  Rhinitis allergic

Population studied

• Short description of the study population:
  Allergologists and pulmonologists prescribing Montelast, 10 mg Film-coated tablets for treatment of bronchial asthma and allergic rhinitis.
• Age groups:
  • 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:
  Asthma patients, Rhinitis allergic patients
• Estimated number of subjects:
  545

Study design details

• Main study objective:
  To evaluate tolerability of Montelast in adults’ treatment of bronchial asthma and allergic rhinitis, or combined. To evaluate clinical efficacy of Montelast in adults’ treatment of bronchial asthma and allergic rhinitis, or combined.
• Data analysis plan:
  Sample size calculation:Number of subjects for drug registration: As per primary endpoint, it is necessary to specify prognostic factors of BA or AR control achievement in 3 months. Factors will be presented as proportions. Maximal proportions’ variability makes nearly 50%. The following formula was used: (Daniel, 1999): n= Z2P(1-P)/ d2 where n = sample size, Z = Z statistics for confidence interval P = expected incidence or proportion d = accuracy Z statistics (Z): to achieve confidence interval 95% (that is recommended for use), Z = 1.96. CI will make 2d. Sample size of 500 subjects will have the power of n.l.t. 80% to evaluate 50±10% variability factors with two-sided confidence level of 0.05.