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AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)
AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

NCT02123667

CompletedN/A

Sponsor: Chiesi Farmaceutici S.p.A.

Conditions: Asthma

Countries: United States, Brazil, Canada, China, Germany, Italy, Netherlands, Spain

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

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility 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

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.
Locations (26)
  • Denver, Colorado, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Houston, Texas, United States
  • Florianópolis, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Montreal, Quebec, Canada
  • Beijing, Beijing Municipality, China
  • Shanghai, Shanghai Municipality, China
  • Hangzhou, China
  • Großhansdorf, Germany
  • Hanover, Germany
  • Leipzig, Germany
  • Ferrara, Italy
  • Naples, Italy
  • Palermo, Italy
  • Parma, Italy
  • Pisa, Italy
  • Verona, Italy
  • 's-Hertogenbosch, Netherlands
  • Alkmaar, Netherlands
  • Groningen, Netherlands
  • Groningen, Netherlands
  • Barcelona, Spain
  • Lugo, Spain