AssessmenT of smalL airways involvemeNT in aSthma (ATLANTIS); multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.
NCT ID NCT02123667
First seen Sep 10, 2026 · Last updated Sep 10, 2026
Summary
Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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872 people
The number who actually took part.
- Started
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Jun 2014
- Finished
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Mar 2017
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Asthmatic patient inclusion criteria 1. Male or female patients aged ≥ 18 and ≤ 65 years, who have signed an Informed Consent form 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. 4. 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 1. Cigarette smoking \> 10 packyears 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. 8. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chetta
Parma, Italy
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Chiesi Clinical Trial Site #0101
Naples, Italy
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Chiesi Clinical Trial Site #0102
Verona, 37134, Italy
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Chiesi Clinical Trial Site #0103
Pisa, 56124, Italy
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Chiesi Clinical Trial Site #0104
Ferrara, 44124, Italy
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Chiesi Clinical Trial Site #0201
Montreal, Quebec, H2X 2P4, Canada
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Chiesi Clinical Trial Site #0301
Hanover, 30625, Germany
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Chiesi Clinical Trial Site #0302
Leipzig, D-04357, Germany
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Chiesi Clinical Trial Site #0303
Großhansdorf, D-22927, Germany
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Chiesi Clinical Trial Site #0401
Lugo, 27003, Spain
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Chiesi Clinical Trial Site #0402
Barcelona, 08026, Spain
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Chiesi Clinical Trial Site #0501
Houston, Texas, 77030, United States
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Chiesi Clinical Trial Site #0502
Durham, North Carolina, 27710, United States
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Chiesi Clinical Trial Site #0503
Denver, Colorado, 80206, United States
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Chiesi Clinical Trial Site #0504
Cleveland, Ohio, 44106, United States
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Dr. J. Vroegop
Groningen, Netherlands
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Dr. M. Broeders
's-Hertogenbosch, Netherlands
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Dr. M. vd Berge
Groningen, Netherlands
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Gao
Beijing, Beijing Municipality, 100730, China
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Prof. Dr. Alberto Cukier
São Paulo, Brazil
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Prof. Dr. Emilio Pizzichini
Florianópolis, Brazil
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Prof. Dr. Rafael Stelmach
São Paulo, Brazil
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Qingling Zhang
Hangzhou, 510120, China
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Scichilone
Palermo, Italy
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W. Boersma
Alkmaar, Netherlands
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Yuanlin Song
Shanghai, Shanghai Municipality, 200032,, China
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