Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD)

NCT04456205 | Unknown

• 1 other identifier: 201908041RIND
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Pulmonary Function Test (FEV1)

  Spirometry test with forced expiratory volume in one second (FEV1)

  6 months

• Pulmonary Function Test (FVC)

  Spirometry test with forced vital capacity (FVC)

  6 months

• Pulmonary Function Test (FEV1/FVC)

  Spirometry test with FEV1/FVC ratio

  6 months

• Frequency of Acute Exacerbation

  Sudden worsening of COPD symptoms with out-patient clinic and emergency department visit or hospitalization

  6 months

Secondary Outcomes (2)

• COPD Assessment Test (CAT) score

  6 months

• Modified Medical Research Council (mMRC) Dyspnea Scale

  6 months

Study Arms (2)

Dual Therapy

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

Triple Therapy

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

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Conformed COPD patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Chung-Yu Chen

Douliu, Yunlin, 640, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: July 2, 2020
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: July 2, 2020

Record last verified: 2020-06

Locations

TW (1)