Multinational, multi-database drug utilization study of inhaled NVA237 in Europe (NVA237 DUS)

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:
  Cohort

  Other
• Non-interventional study design, other:
  Exploratory, descriptive study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03BB06) glycopyrronium bromide

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

Population studied

• Short description of the study population:
  From the databases containing available NVA237-exposure data from November 2012 onwards, a cohort of patients with a first-time prescription or dispensation of NVA237 was selected. Patients without one year of database history before the first prescription of NVA237 were excluded from the study. No further exclusion criteria were applied.
• Age groups:
  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)
• Special population of interest:
  Hepatic impaired

  Other

  Pregnant women

  Renal impaired
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  1. To determine the proportion of patients using NVA237 who also have cardiovascular or cerebrovascular co-morbidities 2. To determine the proportion of patients using NVA237 who have missing information as per RMP or high risk treatment conditions: 2a) A history of the various conditions2b) Off-label use. 2c) Uninterrupted use for more than one year.
• Data analysis plan:
  Descriptive statistics will be used. Categorical data will be presented as counts (n) and proportions (%) along with (95% confidence intervals). For continuous data, the number of observations (n), mean, standard deviation, median (with interquartile range) will be presented. Yearly progress reports will be prepared containing country specific data. Only for the final analysis (end of study), pooled data will be presented.

Documents

Study results

NVA237A2401T-Redacted-Final-Study-Report