AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

Chiesi

Status: Completed

Conditions: Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT02123667

CCD-01535AC1-01 (Other Identifier)

Details and patient eligibility

About

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

Full description

Large non pharmacological studies on Small Airways Disease

Enrollment: 872 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

5. 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

6. Cigarette smoking > 10 packyears

7. diagnosis of COPD

8. Asthma exacerbation in the 8 weeks prior to baseline visit

9. 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.

10. Pregnant or lactating women

11. Participation in an interventional clinical trial <12 weeks preceding baseline visit

12. Inability to comply with study procedures.

13. Alcohol or drug abuse. Healthy subject exclusion criteria

14. 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.

15. 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 design

872 participants in 2 patient groups

Asthmatic patients

Description:

asthmatic patients 18 to 65

Healthy volunteers

Description:

Volunteers 18 to 65