AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

Study Identifier:
CCD-01535AC1-01
ClinicalTrials.gov Identifier:
NCT02123667
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
    Date
    Jun 2014 - Mar 2017
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 18 - 65 Years
    Requirements Information
    Inclusion and Exclusion Criteria
    • Asthmatic patient inclusion criteria
    • Male or female patients aged ≥ 18 and ≤ 65 years, who have signed an Informed Consent form
    • Clinical diagnosis of asthma f
    • Positive response to methacholine challenge test
    • Positive response to a reversibility test or
    • Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) \> 20% or
    • Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment.
    • Patients with stable asthma.
    • Current smoker, ex-smoker or lifelong non-smoker Healthy subject inclusion criteria
    • 1\. 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
    • Cigarette smoking \> 10 packyears
    • diagnosis of COPD
    • Asthma exacerbation in the 8 weeks prior to baseline visit
    • 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.
    • Pregnant or lactating women
    • Participation in an interventional clinical trial \<12 weeks preceding baseline visit
    • Inability to comply with study procedures.
    • Alcohol or drug abuse. Healthy subject exclusion criteria
    • 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.
    Healthy Volunteers
    Yes

    Protocol Summary

    Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.

    Study Locations

    Location
    Status
    Location
    Chiesi Clinical Trial Site #0503
    Denver, Colorado, United States, 80206
    Status
    N/A
    Location
    Chiesi Clinical Trial Site #0502
    Durham, North Carolina, United States, 27710
    Status
    N/A
    Location
    Chiesi Clinical Trial Site #0504
    Cleveland, Ohio, United States, 44106
    Status
    N/A
    Location
    Chiesi Clinical Trial Site #0501
    Houston, Texas, United States, 77030
    Status
    N/A
    Location
    Prof. Dr. Emilio Pizzichini
    Florianópolis, Brazil
    Status
    N/A
    Location
    Prof. Dr. Alberto Cukier
    São Paulo, Brazil
    Status
    N/A
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    Study Publications

    Kole TM, Vanden Berghe E, Kraft M, Vonk JM, Nawijn MC, Siddiqui S, Sun K, Fabbri LM, Rabe KF, Chung KF, Nicolini G, Papi A, Brightling C, Singh D, van der Molen T, Dahlen SE, Agusti A, Faner R, Wedzicha JA, Donaldson GC, Adcock IM, Lahousse L, Kerstjens HAM, van den Berge M; ATLANTIS; U-BIOPRED; CADSET investigators. Predictors and associations of the persistent airflow limitation phenotype in asthma: a post-hoc analysis of the ATLANTIS study. Lancet Respir Med. 2023 Jan;11(1):55-64. doi: 10.1016/S2213-2600(22)00185-0. Epub 2022 Jul 27.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.Karp T, Merid SK, Kermani NZ, Faiz A, Gillett TE, Bults R, Raby KL, Kerstjens HAM, Nawijn MC, Piraino A, Kraft M, Beghe B, Rabe KF, Papi A, Brightling C, Singh D, Kocks JH, Siddiqui S, Adcock IM, Chung KF, Bhavsar P, Koppelman GH, Melen E, Guryev V, van den Berge M. Nasal gene expression shows a distinct signature in type 2-high asthma but not in type 2-low disease. J Allergy Clin Immunol. 2026 Apr;157(4):879-889. doi: 10.1016/j.jaci.2025.10.036. Epub 2026 Jan 2.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.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.