Chronic obstructive pulmonary disease COPD
Conditions
Interventions
Guided ICS withdrawal in optimised COPD management. All study participants (of
both study arms) will receive recommendations on optimal bronchodilator therapy
and a personalized action plan to recog
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Aged 40 years or older; - Confirmed diagnosis of COPD: o COPD diagnosis in the medical record (ICPC code R95 or R91); o Most recent spirometry result is less than two years old and shows a FEV1/FVC ratio
Exclusion criteria
Exclusion criteria: -Diagnosis of asthma in the medical record (ICPC code R96); -A spirometry test that has demonstrated airflow reversibility (i.e., post-bd FEV1 improvement of at least 12% and 200 ml compared to baseline and/or post-bd FEV1 improvement of 9% of the baseline FEV1 % predicted value) that preceded the initiation of ICS treatment; -Allergic respiratory disease which has been confirmed by a positive skin prick test or specific IgE in serum as documented in the medical record, in combination with a documented history respiratory allergic symptoms. -two or more exacerbations in the previous 12 months that were treated with oral corticosteroids, antibiotics, or both; -one or more exacerbations in the previous 12 months that required a visit to an emergency care facility or hospital admission. -daily use of oral steroids. Page 18 for full list of criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of exacerbation-free weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| successful cessation of ICS, time to first exacerbation, number of moderate and severe exacerbations, health-related quality of life, health status, and pneumonias. Moreover, information on the process of care and costs will be collected. | — |
Countries
Netherlands
Outcome results
None listed