Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD)

  • STATUS
    Recruiting
  • days left to enroll
    79
  • participants needed
    200
  • sponsor
    National Taiwan University Hospital
Updated on 24 January 2021
pneumonia
corticosteroids
pulmonary function test
inhaled steroids
bronchodilator
eosinophil count
acute exacerbation of chronic obstructive pulmonary disease

Summary

According to the WISDOM study, withdraw of inhaled steroids has no effect on the acute exacerbation of chronic obstructive pulmonary disease (COPD), but the lung function of patients with COPD is significantly reclined. In the subgroup analysis of this study, patients with COPD were found to have continued to use inhaled steroids in patients with eosinophilic leukocytes greater than 400 cells/ul or whom has more than two episodes of exacerbation per year. However, in SUNSET study, it was pointed out that withdraw of inhaled steroids had no effect on lung function in patients with COPD, but it was also found that in patients with COPD, eosinophilic leukocytes in the blood were greater than 300 cells/ul, have a better therapeutic response in steroid inhalation. In addition, some studies have shown that in patients with COPD, a decline in lung function after discontinuation of inhaled steroids can make the patient's clinical symptoms worse and increase the risk of acute exacerbations. However, in other comprehensive analytical studies, there are different outcomes. There is no statistically significant difference in the risk of acute exacerbation in patients with COPD after discontinuation of inhaled steroids.

In past studies, it was noted that inhaled steroids cause an increased risk of pneumonia in patients with COPD. However, in these studies, the diagnosis of pneumonia was only from the clinician's suspicion without clear symptom assessment, laboratory examination, microbiological evidence or imaging assessment. Therefore, further research is needed to assess whether patients are suitable for the reduction of inhaled steroids and the impact of COPD in clinical treatment.

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease), Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease), Reactive Airway Disease, Inhaled Corticosteroid, chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease (copd)
Clinical Study IdentifierNCT04456205
SponsorNational Taiwan University Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Confirmed patients with COPD (at least one lung function test post bronchodilator FEV1/FVC <70% before the start of the study)
Age 40 years old
No acute attack record within half a year
Triple therapy (dual long-acting inhaled bronchodilator and inhaled steroid) is stable for more than six months
Eosinophil count in blood <300 cells/ul
Clinical symptom assessment CAT score <20

Exclusion Criteria

Suspected or diagnosed with asthma
Age <40 years
Within half a year, there is a record of moderate to severe acute attacks
Eosinophil count in blood 300 cells/ul
Clinical symptom assessment CAT score 20
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