Does monitored discontinuation of inhaled corticosteroids (ICS) for primary care COPD patients without a clear indication for ICS according to current guidelines results in a reduction of ICS use without adverse health effects. - WHISPER study

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 65 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- 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 <0.7 (If no recent spirometry results are available, the patient will be scheduled for a diagnostic spirometric test);
•- ICS treatment for at least the past 6 months;
•- No clear indication to continue ICS treatment according to current NHG COPD guideline recommendations (indications for ICS treatment);
•- Willing to provide written informed consent;
•Page 17 of study protocol for full list of 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.

发起方

niversitair Medisch Centrum Sint Radboud