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AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

Sponsor
Chiesi Farmaceutici S.p.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT02123667
Collaborator
(none)
872
Enrollment
26
Locations
32.1
Actual Duration (Months)
33.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Large non pharmacological studies on Small Airways Disease

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    872 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS); Multinational, Multicentre, Non-pharmacological Intervention, Cross-sectional and Longitudinal Study.
    Actual Study Start Date :
    Jun 30, 2014
    Actual Primary Completion Date :
    Mar 4, 2017
    Actual Study Completion Date :
    Mar 4, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Asthmatic patients

    asthmatic patients 18 to 65
    Healthy volunteers

    Volunteers 18 to 65

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    3. Positive response to methacholine challenge test

    4. Positive response to a reversibility test or

    5. Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) > 20% or

    6. Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment.

    7. Patients with stable asthma.

    8. Current smoker, ex-smoker or lifelong non-smoker Healthy subject inclusion criteria

    9. 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

    10. Cigarette smoking > 10 packyears

    11. diagnosis of COPD

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

    13. 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.

    14. Pregnant or lactating women

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

    16. Inability to comply with study procedures.

    17. Alcohol or drug abuse. Healthy subject exclusion criteria

    18. 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.

    19. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chiesi Clinical Trial Site #0503 Denver Colorado United States 80206
    2 Chiesi Clinical Trial Site #0502 Durham North Carolina United States 27710
    3 Chiesi Clinical Trial Site #0504 Cleveland Ohio United States 44106
    4 Chiesi Clinical Trial Site #0501 Houston Texas United States 77030
    5 Prof. Dr. Emilio Pizzichini Florianópolis Brazil
    6 Prof. Dr. Alberto Cukier São Paulo Brazil
    7 Prof. Dr. Rafael Stelmach São Paulo Brazil
    8 Chiesi Clinical Trial Site #0201 Montreal Quebec Canada H2X 2P4
    9 Gao Beijing Beijing China 100730
    10 Yuanlin Song Shanghai Shanghai China 200032,
    11 Qingling Zhang Hangzhou China 510120
    12 Chiesi Clinical Trial Site #0303 Grosshansdorf Germany D-22927
    13 Chiesi Clinical Trial Site #0301 Hannover Germany 30625
    14 Chiesi Clinical Trial Site #0302 Leipzig Germany D-04357
    15 Chiesi Clinical Trial Site #0104 Ferrara Italy 44124
    16 Chiesi Clinical Trial Site #0101 Napoli Italy
    17 Scichilone Palermo Italy
    18 Chetta Parma Italy
    19 Chiesi Clinical Trial Site #0103 Pisa Italy 56124
    20 Chiesi Clinical Trial Site #0102 Verona Italy 37134
    21 W. Boersma Alkmaar Netherlands
    22 Dr. J. Vroegop Groningen Netherlands
    23 Dr. M. vd Berge Groningen Netherlands
    24 Dr. M. Broeders Hertogenbosch Netherlands
    25 Chiesi Clinical Trial Site #0402 Barcelona Spain 08026
    26 Chiesi Clinical Trial Site #0401 Lugo Spain 27003

    Sponsors and Collaborators

    • Chiesi Farmaceutici S.p.A.

    Investigators

    • Principal Investigator: Monica Kraft, MD, Duke University
    • Principal Investigator: Dirkje S Postma, Prof. Dr., University Medical Center Groningen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chiesi Farmaceutici S.p.A.
    ClinicalTrials.gov Identifier:
    NCT02123667
    Other Study ID Numbers:
    • CCD-01535AC1-01
    • CCD-01535AC1-01
    First Posted:
    Apr 25, 2014
    Last Update Posted:
    Jul 31, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Jul 31, 2020