Drug Utilisation Study for Olodaterol

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03AC18) indacaterol

  indacaterol

  (R03AC19) olodaterol

  olodaterol
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  All subjects enrolled in the selected study databases at the date olodaterol became available in each database’s country. The study groups are those subjects from the source population who receive a first dispensing for single-agent formulations of olodaterol for the primary objective or indacaterol for the secondary objective and have at least 12 months of continuous enrolment in the study databases.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  To quantify the frequency of off-label use of olodaterol among new users of these olodaterol and indacaterol (i.e. the proportion of new users who do not have COPD) and to describe the baseline characteristics of new users of olodaterol.
• Outcomes:
  The primary outcome is the prevalence of off-label prescribing among new users of olodaterol. The secondary outcome is the prevalence of off-label prescribing among new users of indacaterol.
• Data analysis plan:
  Statistical analyses will be descriptive in nature. Descriptive statistics will include the absolute and relative number of subjects, mean, median, standard deviation, and range for continuous variables. Statistical inference will not be performed (e.g. no P values will be generated). Where appropriate, two-sided 95% confidence intervals will be presented. All analyses will be conducted separately in each study database and will be further analysed separately by new users of olodaterol and by new users of indacaterol, further stratified by treatment-naïve subjects and switchers. In the French IMS RWE LPD, data will be analysed separately for the panel of general practitioners and for the panel of pulmonologists. Analysis for each report (i.e. interim and final) will include data on all patients starting treatment with olodaterol or indacaterol from the start of such treatment up to the latest available data.

Documents

Study results

1222_53_Olodaterol DUS_Final Report_Final_20Aug2018_clean_Abstract (pages 6 to 13)_Redacted

Study publications

Rebordosa, C., Houben, E., Laugesen, K. et al. No Evidence of Off-label Use of …

Rebordosa C, Houben E, Laugesen K, Asmar J, Montonen JT, Aguado J, et al. Utili…