AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)
NCT ID: NCT02123667
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
872 participants
OBSERVATIONAL
2014-06-30
2017-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Asthmatic patients
asthmatic patients 18 to 65
No interventions assigned to this group
Healthy volunteers
Volunteers 18 to 65
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of asthma f
1. Positive response to methacholine challenge test
2. Positive response to a reversibility test or
3. Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) \> 20% or
4. Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment.
3. Patients with stable asthma.
Exclusion Criteria
2. diagnosis of COPD
3. Asthma exacerbation in the 8 weeks prior to baseline visit
4. 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.
5. Pregnant or lactating women
6. Participation in an interventional clinical trial \<12 weeks preceding baseline visit
7. Inability to comply with study procedures.
1\. 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.
4\. 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Monica Kraft, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Dirkje S Postma, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Chiesi Clinical Trial Site #0503
Denver, Colorado, United States
Chiesi Clinical Trial Site #0502
Durham, North Carolina, United States
Chiesi Clinical Trial Site #0504
Cleveland, Ohio, United States
Chiesi Clinical Trial Site #0501
Houston, Texas, United States
Prof. Dr. Emilio Pizzichini
Florianópolis, , Brazil
Prof. Dr. Alberto Cukier
São Paulo, , Brazil
Prof. Dr. Rafael Stelmach
São Paulo, , Brazil
Chiesi Clinical Trial Site #0201
Montreal, Quebec, Canada
Gao
Beijing, Beijing Municipality, China
Yuanlin Song
Shanghai, Shanghai Municipality, China
Qingling Zhang
Hangzhou, , China
Chiesi Clinical Trial Site #0303
Großhansdorf, , Germany
Chiesi Clinical Trial Site #0301
Hanover, , Germany
Chiesi Clinical Trial Site #0302
Leipzig, , Germany
Chiesi Clinical Trial Site #0104
Ferrara, , Italy
Chiesi Clinical Trial Site #0101
Napoli, , Italy
Scichilone
Palermo, , Italy
Chetta
Parma, , Italy
Chiesi Clinical Trial Site #0103
Pisa, , Italy
Chiesi Clinical Trial Site #0102
Verona, , Italy
Dr. M. Broeders
's-Hertogenbosch, , Netherlands
W. Boersma
Alkmaar, , Netherlands
Dr. J. Vroegop
Groningen, , Netherlands
Dr. M. vd Berge
Groningen, , Netherlands
Chiesi Clinical Trial Site #0402
Barcelona, , Spain
Chiesi Clinical Trial Site #0401
Lugo, , Spain
Countries
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References
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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.
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 Sep 29:S2213-2600(25)00283-8. doi: 10.1016/S2213-2600(25)00283-8. Online ahead of print.
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.
Other Identifiers
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CCD-01535AC1-01
Identifier Type: OTHER
Identifier Source: secondary_id
CCD-01535AC1-01
Identifier Type: -
Identifier Source: org_study_id
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