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Completed

NCT Number: NCT02123667

AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Emilio Pizzichini, Florianópolis, Brazil

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About this study

Large non pharmacological studies on Small Airways Disease

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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
  • 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.
  • 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.

Treatment and study plan

Primary outcomes

  1. To determine the role of small airways abnormalities in the clinical manifestations of asthma.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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

Acronym: ATLANTIS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2014
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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