Multinational, multi-database drug utilization study of indacaterol/glycopyrronium bromide in Europe

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• 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:
  INDACATEROL

  GLYCOPYRRONIUM BROMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL04) indacaterol and glycopyrronium bromide

  indacaterol and glycopyrronium bromide
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  The study population will comprise of all patients who newly initiated therapy with QVA149, as recorded in the databases. Initiation of therapy will be defined as a first prescription or dispensing of QVA149 preceded by at least 1 year of QVA149-free valid database history. The date of the first prescription of QVA149 will be defined as index date.
• Age groups:
  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The proportion of patients using QVA149 who do not meet criteria specified in the QVA149 label (‘off-label use’) i.e. use in patients younger than 18 years or in patients without a diagnosis of COPD, with asthma/asthma and COPD without concomitant use of inhaled corticosteroids (ICS)* -Proportion of patients using QVA149 who have missing information as per RMP or high risk treatment conditions
• Data analysis plan:
  The study will not test any a priori hypothesis.Descriptive statistics will be used and categorical data will be presented in counts (n) and proportions (%) with 95% confidence intervals (95% CIs). 95% CIs will be calculated either based on the normal distribution or based on the binomial distribution. For continuous data, the number of observations (n), mean, standard deviation and median (with inter-quartile range) will be presented.Switching characteristics will be described by counts, proportions and 95% CI both from switching from QVA149 to another respiratory drug (LABA, LAMA, LABA+ICS, loose combination LABA+LAMA, loose combination LABA+ICS, loose combination LAMA+ICS or triple therapy) and vice versa.

Documents

Study results

QVA149A2401-Redacted-Final-Study-Report