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.
- Conditions
- Chronic obstructive pulmonary diseaseCOPD10006436
- Registration Number
- NL-OMON42531
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of exacerbation-free weeks. </p><br>
- Secondary Outcome Measures
Name Time Method <p>successful cessation of ICS, time to first exacerbation, number of moderate and<br /><br>severe exacerbations, health-related quality of life, health status, and<br /><br>pneumonias. Moreover, information on the process of care and costs will be<br /><br>collected. </p><br>