Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-20 @ 8:32 PM
Study NCT ID:
NCT02123667
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Optional bronchoscopy with endobronchial and trans-bronchial biopsy will be applicable in selected sites only in EU and US. Total number of inflammatory cells and quantification of specific cells including eosinophils, T cells and macrophages will be performed. Gene expression profiles (including RNA) will be performed at a later date for future analysis on the pathobiology of asthma which will be defined in future specific protocols'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 872}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2014-04-24', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the role of small airways abnormalities in the clinical manifestations of asthma.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '30876830', 'type': 'RESULT', 'citation': 'Postma DS, Brightling C, Baldi S, Van den Berge M, Fabbri LM, Gagnatelli A, Papi A, Van der Molen T, Rabe KF, Siddiqui S, Singh D, Nicolini G, Kraft M; ATLANTIS study group. Exploring the relevance and extent of small airways dysfunction in asthma (ATLANTIS): baseline data from a prospective cohort study. Lancet Respir Med. 2019 May;7(5):402-416. doi: 10.1016/S2213-2600(19)30049-9. Epub 2019 Mar 12.'}, {'pmid': '41038213', 'type': 'DERIVED', 'citation': 'Galant SP, Kuks PJM, Kole TM, Kraft M, Siddiqui S, Fabbri LM, Beghe B, Rabe KF, Papi A, Brightling CE, Singh D, Kocks JWH, Franzini L, Vonk JM, Kerstjens HAM, Heijink IH, Pouwels SD, Slebos DJ, van den Berge M. Assessment of the role of small airway dysfunction in relation to exacerbation risk in patients with well controlled asthma (ATLANTIS): an observational study. Lancet Respir Med. 2025 Nov;13(11):990-1000. doi: 10.1016/S2213-2600(25)00283-8. Epub 2025 Sep 29.'}, {'pmid': '38901877', 'type': 'DERIVED', 'citation': 'Kole TM, Muiser S, Kraft M, Siddiqui S, Fabbri LM, Rabe KF, Papi A, Brightling C, Singh D, van der Molen T, Nawijn MC, Kerstjens HAM, van den Berge M. Sex differences in asthma control, lung function and exacerbations: the ATLANTIS study. BMJ Open Respir Res. 2024 Jun 19;11(1):e002316. doi: 10.1136/bmjresp-2024-002316.'}]}, 'descriptionModule': {'briefSummary': 'Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.', 'detailedDescription': 'Large non pharmacological studies on Small Airways Disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '900 subjects divided into 800 asthmatic patients and 100 healthy controls will be included. Recruitment will be balanced, at the extent possible, in order to achieve at least \\> 150 patients each for steps 1 - 4 and \\> 50 patients for step 5 as indicated in the international guidelines (GINA 2012) on the basis of their previous therapy. The 150 healthy controls will be recruited on the basis of absence of respiratory symptoms, airway obstruction and hyper responsiveness.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Asthmatic patient inclusion criteria\n\n1. Male or female patients aged ≥ 18 and ≤ 65 years, who have signed an Informed Consent form\n2. Clinical diagnosis of asthma f\n\n 1. Positive response to methacholine challenge test\n 2. Positive response to a reversibility test or\n 3. Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) \\> 20% or\n 4. Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment.\n3. Patients with stable asthma.\n4. Current smoker, ex-smoker or lifelong non-smoker Healthy subject inclusion criteria\n\n1\\. Male or female patients aged ≥ 18 and ≤ 65 years 2. No clinical history of asthma or COPD 3. Current smoker, ex-smoker or lifelong non-smokers 4. Normal spirometry 5. Normal airways responsiveness Asthmatic patient exclusion criteria\n\n1. Cigarette smoking \\> 10 packyears\n2. diagnosis of COPD\n3. Asthma exacerbation in the 8 weeks prior to baseline visit\n4. Clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might compromise the results or interpretation of the study.\n5. Pregnant or lactating women\n6. Participation in an interventional clinical trial \\<12 weeks preceding baseline visit\n7. Inability to comply with study procedures.\n8. Alcohol or drug abuse. Healthy subject exclusion criteria\n\n1\\. Cigarette smoking history \\> 10 packyears 2. Diagnosed upper and/or lower respiratory disease(s). 3. Clinical or functional uncontrolled haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that mightp compromise the results or interpretation of the study.\n\n4\\. Pregnant or lactating women 5. Participation in an interventional clinical trial \\<12 weeks preceding baseline visit 6. Inability to comply with study procedures. 7. Alcohol or drug abuse.'}, 'identificationModule': {'nctId': 'NCT02123667', 'acronym': 'ATLANTIS', 'briefTitle': 'AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS); Multinational, Multicentre, Non-pharmacological Intervention, Cross-sectional and Longitudinal Study.', 'orgStudyIdInfo': {'id': 'CCD-01535AC1-01'}, 'secondaryIdInfos': [{'id': 'CCD-01535AC1-01', 'type': 'OTHER', 'domain': 'Chiesi Farmaceutici'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthmatic patients', 'description': 'asthmatic patients 18 to 65'}, {'label': 'Healthy volunteers', 'description': 'Volunteers 18 to 65'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Chiesi Clinical Trial Site #0503', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Chiesi Clinical Trial Site #0502', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Chiesi Clinical Trial Site #0504', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Chiesi Clinical Trial Site #0501', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Florianópolis', 'country': 'Brazil', 'facility': 'Prof. Dr. Emilio Pizzichini', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Prof. Dr. Alberto Cukier', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Prof. Dr. Rafael Stelmach', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'H2X 2P4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Chiesi Clinical Trial Site #0201', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Gao', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200032,', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Yuanlin Song', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '510120', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Qingling Zhang', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': 'D-22927', 'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'Chiesi Clinical Trial Site #0303', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Chiesi Clinical Trial Site #0301', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-04357', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Chiesi Clinical Trial Site #0302', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '44124', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'Chiesi Clinical Trial Site #0104', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Chiesi Clinical Trial Site #0101', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Scichilone', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Parma', 'country': 'Italy', 'facility': 'Chetta', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Chiesi Clinical Trial Site #0103', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'Chiesi Clinical Trial Site #0102', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Dr. M. Broeders', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'W. Boersma', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Dr. J. Vroegop', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Dr. M. vd Berge', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '08026', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Chiesi Clinical Trial Site #0402', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '27003', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Chiesi Clinical Trial Site #0401', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}], 'overallOfficials': [{'name': 'Monica Kraft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Dirkje S Postma, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}