AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

NCT02123667 | Completed DMC

• 1 other identifier: CCD-01535AC1-01
• Study Type: observational
• Target: 872
• Locations: 8 countries
• Sites: 26

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• To determine the role of small airways abnormalities in the clinical manifestations of asthma.

  1 year

Study Arms (2)

Asthmatic patients

asthmatic patients 18 to 65

Healthy volunteers

Volunteers 18 to 65

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (26)

Chiesi Clinical Trial Site #0503

Denver, Colorado, 80206, United States

Location

Chiesi Clinical Trial Site #0502

Durham, North Carolina, 27710, United States

Location

Chiesi Clinical Trial Site #0504

Cleveland, Ohio, 44106, United States

Location

Chiesi Clinical Trial Site #0501

Houston, Texas, 77030, United States

Location

Prof. Dr. Emilio Pizzichini

Florianópolis, Brazil

Location

Prof. Dr. Alberto Cukier

São Paulo, Brazil

Location

Prof. Dr. Rafael Stelmach

São Paulo, Brazil

Location

Chiesi Clinical Trial Site #0201

Montreal, Quebec, H2X 2P4, Canada

Location

Gao

Beijing, Beijing Municipality, 100730, China

Location

Yuanlin Song

Shanghai, Shanghai Municipality, 200032,, China

Location

Qingling Zhang

Hangzhou, 510120, China

Location

Chiesi Clinical Trial Site #0303

Großhansdorf, D-22927, Germany

Location

Chiesi Clinical Trial Site #0301

Hanover, 30625, Germany

Location

Chiesi Clinical Trial Site #0302

Leipzig, D-04357, Germany

Location

Chiesi Clinical Trial Site #0104

Ferrara, 44124, Italy

Location

Chiesi Clinical Trial Site #0101

Naples, Italy

Location

Scichilone

Palermo, Italy

Location

Chetta

Parma, Italy

Location

Chiesi Clinical Trial Site #0103

Pisa, 56124, Italy

Location

Chiesi Clinical Trial Site #0102

Verona, 37134, Italy

Location

Dr. M. Broeders

's-Hertogenbosch, Netherlands

Location

W. Boersma

Alkmaar, Netherlands

Location

Dr. J. Vroegop

Groningen, Netherlands

Location

Dr. M. vd Berge

Groningen, Netherlands

Location

Chiesi Clinical Trial Site #0402

Barcelona, 08026, Spain

Location

Chiesi Clinical Trial Site #0401

Lugo, 27003, Spain

Location

Related Publications (5)

• 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.

  PMID: 35907424 BACKGROUND

• 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: 41038213 BACKGROUND

• 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.

  PMID: 41485495 BACKGROUND

• 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: 30876830 RESULT

• 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.

  PMID: 38901877 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Monica Kraft, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Dirkje S Postma, Prof. Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 25, 2014
• Study Start: June 30, 2014
• Primary Completion: March 4, 2017
• Study Completion: March 4, 2017
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

DE (3); CA (1); IT (6); ES (2); CN (3); US (4); NL (4); BR (3)