Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT01287351
Eligibility Criteria:
Inclusion Criteria:
* Aged: 5-80 years:
* Paediatric cohort (aged 5-11 years), and
* Adult cohort (aged 12-60 years)
* Non-smokers aged 61-80 years
* Evidence of asthma:
* a diagnostic code for asthma, (ICD 9 codes: 493xx) or
* ≥2 prescriptions for asthma at different points at any time
* Be on current asthma therapy
* ≥1 other asthma prescription during the outcome period
* Have at least one year of baseline data (prior to the IPD) and at least one year of outcome data (following the IPD).
Exclusion Criteria:
* had been diagnosed with any chronic respiratory disease at any time other than asthma
* received maintenance oral steroid therapy during baseline.
Updated inclusion criteria - used in the latest analysis:
* Aged 12-60 years (paediatrics included in original study - removed to make comparable with USA data)
* Evidence of asthma: a diagnostic code of asthma or ≥2 scripts for asthma in baseline year at different points in time
* Have definite dosing instructions
* Have at least 1 year of up-to-standard (UTS) baseline data before IPD
* Have at least 1 year of UTS outcome data after IPD. Index dates from 1998 onwards were accepted in the study.
Updated exclusion criteria - used in the latest analysis:
* Had a diagnostic read code for chronic obstructive pulmonary disease (COPD) at any time
* Had a diagnostic read code for chronic respiratory disease at any time
* Were on maintenance oral steroid therapy at baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
80 Years
Study:
NCT01287351
Study Brief:
Protocol Section:
NCT01287351