Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04456205
Status:
UNKNOWN
Last Update Posted:
2020-07-02
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Function Test (FEV1)', 'timeFrame': '6 months', 'description': 'Spirometry test with forced expiratory volume in one second (FEV1)'}, {'measure': 'Pulmonary Function Test (FVC)', 'timeFrame': '6 months', 'description': 'Spirometry test with forced vital capacity (FVC)'}, {'measure': 'Pulmonary Function Test (FEV1/FVC)', 'timeFrame': '6 months', 'description': 'Spirometry test with FEV1/FVC ratio'}, {'measure': 'Frequency of Acute Exacerbation', 'timeFrame': '6 months', 'description': 'Sudden worsening of COPD symptoms with out-patient clinic and emergency department visit or hospitalization'}], 'secondaryOutcomes': [{'measure': 'COPD Assessment Test (CAT) score', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Modified Medical Research Council (mMRC) Dyspnea Scale', 'timeFrame': '6 months', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD', 'Inhaled Corticosteroid']}, 'descriptionModule': {'briefSummary': "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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Conformed COPD patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed patients with COPD (at least one lung function test post bronchodilator FEV1/FVC \\<70% before the start of the study)\n* Age ≥ 40 years old\n* No acute attack record within half a year\n* Triple therapy (dual long-acting inhaled bronchodilator and inhaled steroid) is stable for more than six months.\n* Eosinophil count in blood \\<300 cells/ul\n* Clinical symptom assessment CAT score \\<20\n\nExclusion Criteria:\n\n* Suspected or diagnosed with asthma\n* Age \\<40 years\n* Within half a year, there is a record of moderate to severe acute attacks\n* Eosinophil count in blood ≥300 cells/ul\n* Clinical symptom assessment CAT score ≥20'}, 'identificationModule': {'nctId': 'NCT04456205', 'briefTitle': 'Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Clinical Effect of Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'orgStudyIdInfo': {'id': '201908041RIND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dual Therapy', 'description': 'Dual Therapy (long-acting muscarinic antagonist \\[LAMA\\] + long-acting beta-agonist \\[LABA\\])'}, {'label': 'Triple Therapy', 'description': 'Triple Therapy (inhaled corticosteroid \\[ICS\\]/ long-acting beta-agonist \\[LABA\\] + long-acting muscarinic antagonist \\[LAMA\\])'}]}, 'contactsLocationsModule': {'locations': [{'zip': '640', 'city': 'Douliu', 'state': 'Yunlin', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chung-Yu Chen', 'role': 'CONTACT', 'email': 'c8101147@ms16.hinet.net', 'phone': '88655323911', 'phoneExt': '5853'}], 'facility': 'Chung-Yu Chen', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}