Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-24 @ 6:11 AM
Study NCT ID:
NCT05398133
Status:
UNKNOWN
Last Update Posted:
2022-05-31
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011657', 'term': 'Pulmonary Eosinophilia'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017681', 'term': 'Hypereosinophilic Syndrome'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'expression of surface markers', 'timeFrame': 'performed up to 3 months after blood and sputum collection', 'description': 'expression of CD125, CD62L, CD66b, CD193, CD11b, CD14'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eosinophil', 'COPD', 'asthma'], 'conditions': ['COPD Asthma', 'Eosinophilic Asthma']}, 'descriptionModule': {'briefSummary': 'Around 1/3 of patients with COPD have elevated eosinophil levels. However, the role of eosinophils in COPD has not been yet understood and is probably different in COPD and in asthma. The aim of this study was to assess the expression of selected surface markers on eosinophils and to assess the gene expression in eosinophils in COPD and asthma patients. We are planning to enrol 12 COPD, 12 asthma and 12 control subjects. Patients will undergo routine clinical assessment, spirometry, blood sampling and sputum induction. Eosinophils will be isolated from blood and sputum. Surface markers on eosinophils will be assessed in flow cytometry, gene expression will be assessed by RNAseq.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD and asthma patients fulfilling the inclusion and exclusion criteria will be recruited from the outpatient clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD according to GOLD 2019 or asthma according to GINA 2021\n* Peripheral blood eosinophil count ≥ 100 / μL\n* Age ≥40 years (COPD), ≥18 years (asthma)\n* History of cigarette smoking: ≥10 pack-years (for COPD)\n* Stable disease period (at least 3 months without exacerbation)\n* Exclusion of parasitic diseases\n* Informed consent to participate in the study\n\nExclusion Criteria:\n\n* COPD and asthma overlap\n* Use of systemic corticosteroids in the 3 months prior to the study\n* Respiratory infection or exacerbation in the 3 months prior to the study\n* Acute and chronic respiratory failure\n* Concomitant diagnoses: systemic connective tissue diseases, malignant neoplasms, severe and / or uncontrolled cardiovascular diseases\n* Use of immunosuppressive or immunomodulating drugs in the 3 months preceding the study\n* Contraindications to sputum induction\n* No consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT05398133', 'briefTitle': 'Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma', 'orgStudyIdInfo': {'id': 'MB/M/15(31)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD patients'}, {'label': 'asthma patients'}, {'label': 'control subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-097', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Katarzyna Gorska, MD PhD', 'role': 'CONTACT', 'email': 'drkpgorska@gmail.com', 'phone': '22 599 27 53'}], 'facility': 'Medical University of Warsaw, Banacha Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Katarzyna Gorska, MD PhD', 'role': 'CONTACT', 'email': 'drkpgorska@gmail.com', 'phone': '22 599 27 53'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}