AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

Study Overview
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Brief Summary
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Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.

Detailed Description
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Large non pharmacological studies on Small Airways Disease

Official Title
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AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS); Multinational, Multicentre, Non-pharmacological Intervention, Cross-sectional and Longitudinal Study.

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthmatic patients<br>asthmatic patients 18 to 65 | |
| Healthy volunteers<br>Volunteers 18 to 65 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the role of small airways abnormalities in the clinical manifestations of asthma. |  | 1 year |