AsthmaATLANTISNCT02123667
AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)
An observational study of Asthma, run by Chiesi Farmaceutici S.p.A. at 26 sites in 8 countries.
Trial summary
Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 872 participants
- Where
- 26 sitesin 8 countries
- Study dates
- 30 Jun 2014to 4 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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
- 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
- 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.
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
Italy6 sites
Chiesi Clinical Trial Site #0104
Ferrara, 44124
Chiesi Clinical Trial Site #0101
Naples
Scichilone
Palermo
Chetta
Parma
Chiesi Clinical Trial Site #0103
Pisa, 56124
Chiesi Clinical Trial Site #0102
Verona, 37134
United States4 sites
Chiesi Clinical Trial Site #0504
Cleveland, Ohio, 44106
Chiesi Clinical Trial Site #0503
Denver, Colorado, 80206
Chiesi Clinical Trial Site #0502
Durham, North Carolina, 27710
Chiesi Clinical Trial Site #0501
Houston, Texas, 77030
Netherlands4 sites
Dr. M. Broeders
's-Hertogenbosch
W. Boersma
Alkmaar
Dr. J. Vroegop
Groningen
Dr. M. vd Berge
Groningen
Brazil3 sites
Prof. Dr. Emilio Pizzichini
Florianópolis
Prof. Dr. Alberto Cukier
São Paulo
Prof. Dr. Rafael Stelmach
São Paulo
China3 sites
Gao
Beijing, Beijing Municipality, 100730
Qingling Zhang
Hangzhou, 510120
Yuanlin Song
Shanghai, Shanghai Municipality, 200032,
Germany3 sites
Chiesi Clinical Trial Site #0303
Großhansdorf, D-22927
Chiesi Clinical Trial Site #0301
Hanover, 30625
Chiesi Clinical Trial Site #0302
Leipzig, D-04357
Spain2 sites
Chiesi Clinical Trial Site #0402
Barcelona, 08026
Chiesi Clinical Trial Site #0401
Lugo, 27003
About this study
Official title: AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS); Multinational, Multicentre, Non-pharmacological Intervention, Cross-sectional and Longitudinal Study.
Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.
Read the detailed description
Large non pharmacological studies on Small Airways Disease
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic patients | asthmatic patients 18 to 65 | |
| Healthy volunteers | Volunteers 18 to 65 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the role of small airways abnormalities in the clinical manifestations of asthma.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study start30 Jun 2014
- Primary completion4 Mar 2017
- Study completion4 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monica Kraft, MD, Principal investigator, Duke UniversityDirkje S Postma, Prof. Dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123667
- Sponsor's protocol ID
- CCD-01535AC1-01
- Other IDs
- CCD-01535AC1-01
- Acronym
- ATLANTIS
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2014
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 35907424Galant 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.
PubMed 41038213Karp 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.
PubMed 41485495Postma 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.
PubMed 30876830Quek E, Pitts O, Clemeno FA, Kocks JWH, Beghe B, Kraft M, Argentina US, Papi A, Rabe KF, van den Berge M, Singh D, Brightling C, Siddiqui S. Oscillometry bronchodilator response testing identifies distinct pathophysiological phenotypes: a post hoc analysis of the ATLANTIS study. ERJ Open Res. 2026 Nov 2;12(6):00314-2026. doi: 10.1183/23120541.00314-2026. eCollection 2026 Nov.
PubMed 42974022Kole 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.
PubMed 38901877
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS); Multinational, Multicentre, Non-pharmacological Intervention, Cross-sectional and Longitudinal Study.
- ClinicalTrials.gov ID
- NCT02123667
- Acronym / sponsor ID
- ATLANTIS / CCD-01535AC1-01
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 872 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 4 Mar 2017 (actual)
- Study completion
- 4 Mar 2017 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.
Detailed description
Large non pharmacological studies on Small Airways Disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthmatic patients | – | –asthmatic patients 18 to 65 |
| Healthy volunteers | – | –Volunteers 18 to 65 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the role of small airways abnormalities in the clinical manifestations of asthma.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 35907424Kole 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.
- Background: PubMed 41038213Galant 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.
- Background: PubMed 41485495Karp 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.
- Results publication: PubMed 30876830Postma 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.
- Derived from this study: PubMed 42974022Quek E, Pitts O, Clemeno FA, Kocks JWH, Beghe B, Kraft M, Argentina US, Papi A, Rabe KF, van den Berge M, Singh D, Brightling C, Siddiqui S. Oscillometry bronchodilator response testing identifies distinct pathophysiological phenotypes: a post hoc analysis of the ATLANTIS study. ERJ Open Res. 2026 Nov 2;12(6):00314-2026. doi: 10.1183/23120541.00314-2026. eCollection 2026 Nov.
- Derived from this study: PubMed 38901877Kole 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Kraft, MD principal investigator
Duke University
Dirkje S Postma, Prof. Dr. principal investigator
University Medical Center Groningen
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Chiesi Farmaceutici S.p.A. at 26 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Italy, United States, Netherlands, Brazil, China and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the role of small airways abnormalities in the clinical manifestations of asthma. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123667, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.