AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

Large non pharmacological studies on Small Airways Disease

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.