COPDNCT04456205
Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD)
An observational study of COPD and Inhaled Corticosteroid, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- COPD, Inhaled Corticosteroid
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2019to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Conformed COPD patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung-Yu Chen
Douliu, Yunlin, 640
Chung-Yu Chen, 88655323911 ext. 5853, c8101147@ms16.hinet.net
About this study
Official title: The Clinical Effect of Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD) Patients
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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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]) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test (FEV1)
Spirometry test with forced expiratory volume in one second (FEV1)
Measured: 6 months
Pulmonary Function Test (FVC)
Spirometry test with forced vital capacity (FVC)
Measured: 6 months
Pulmonary Function Test (FEV1/FVC)
Spirometry test with FEV1/FVC ratio
Measured: 6 months
Frequency of Acute Exacerbation
Sudden worsening of COPD symptoms with out-patient clinic and emergency department visit or hospitalization
Measured: 6 months
Secondary outcomes (2)
COPD Assessment Test (CAT) score
COPD Assessment Test (CAT) score ( a patient-completed questionnaire assessing all aspects of the impact of COPD, including cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels) provides a score of 0-40 to indicate the impact of COPD.
Measured: 6 months
Modified Medical Research Council (mMRC) Dyspnea Scale
Modified Medical Research Council (mMRC) Dyspnea Scale is consisting of just five items containing statements about the impact of breathlessness on the individual and leading to a grade from 1 to 5. (1. Not troubled by breathless except on strenuous exercise; 2. Short of breath when hurrying on a level or when walking up a slight hill; 3. Walks slower than most people on the level, stops after a mile or so, or stops after 15 min walking at own pace; 4. Stops for breath after walking 100 yards, or after a few minutes on level ground; 5. Too breathless to leave the house, or breathless when dressing/undressing).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Oct 2019
- Primary completionOct 2021 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456205
- Sponsor's protocol ID
- 201908041RIND
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT04456205
- Acronym / sponsor ID
- 201908041RIND
- Conditions
- COPD, Inhaled Corticosteroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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]) |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Conformed COPD patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary Function Test (FEV1)
Time frame: 6 months
Spirometry test with forced expiratory volume in one second (FEV1)
Pulmonary Function Test (FVC)
Time frame: 6 months
Spirometry test with forced vital capacity (FVC)
Pulmonary Function Test (FEV1/FVC)
Time frame: 6 months
Spirometry test with FEV1/FVC ratio
Frequency of Acute Exacerbation
Time frame: 6 months
Sudden worsening of COPD symptoms with out-patient clinic and emergency department visit or hospitalization
2 secondary outcomes
COPD Assessment Test (CAT) score
Time frame: 6 months
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Inhaled Corticosteroid, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test (FEV1) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.