Assessment of the safety of LABAs in asthma in routine care by combining healthcare databases and direct patient follow-up (ASTRO-LAB)

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

  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03) DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

  DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Persistant asthma patients in France and in UK included between May 2013 and February 2015.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The overall objective of the project is to compare the rate of severe asthma exacerbation in children and adults treated by LABAs without ICs and with concomitant ICs with the rate amongst those treated by ICs without LABAs under the conditions of routine clinical care, after adjusting for baseline differences in severity.
• Outcomes:
  Severe Asthma exacerbation. In the Astro-lab study, the definition of severe asthma exacerbation will be the combination of patient-reported courses of oral corticosteroids for asthma, asthma-related urgent medical visits, asthma-related hospital contacts or death. Adherence, Asthma control and quality of life.
• Data analysis plan:
  Descriptive statistics will be provided for each exposure group. In addition different types of analysis are planned : - analysis based on the 4 initial exposure groups "intention to treat"- Cohort analysis with time-dependent variables analysis- Case -crossover study approach (if applicable)- Nested case control study (if applicable)

Documents

Study results

ASTROLAB_PR3_PublishableSummary

Study publications

ASTROLAB website