Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT04456205

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-10-31

Brief 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.

Conditions

COPD; Inhaled Corticosteroid

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Dual Therapy

Dual Therapy (long-acting muscarinic antagonist \[LAMA\] + long-acting beta-agonist \[LABA\])

No interventions assigned to this group

Triple Therapy

Triple Therapy (inhaled corticosteroid \[ICS\]/ long-acting beta-agonist \[LABA\] + long-acting muscarinic antagonist \[LAMA\])

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chung-Yu Chen

Douliu, Yunlin, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Chung-Yu Chen

Role: primary

c8101147@ms16.hinet.net

88655323911 ext. 5853

Other Identifiers

201908041RIND

Identifier Type: -

Identifier Source: org_study_id