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

July 30, 2020 updated by: Chiesi Farmaceutici S.p.A.

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

Large non pharmacological studies on Small Airways Disease

Study Type

Observational

Enrollment (Actual)

872

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Florianópolis, Brazil
        • Prof. Dr. Emilio Pizzichini
      • São Paulo, Brazil
        • Prof. Dr. Alberto Cukier
      • São Paulo, Brazil
        • Prof. Dr. Rafael Stelmach
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 2P4
        • Chiesi Clinical Trial Site #0201
  • China
      • Hangzhou, China, 510120
        • Qingling Zhang
    • Beijing
      • Beijing, Beijing, China, 100730
        • Gao
    • Shanghai
      • Shanghai, Shanghai, China, 200032,
        • Yuanlin Song
  • Germany
      • Grosshansdorf, Germany, D-22927
        • Chiesi Clinical Trial Site #0303
      • Hannover, Germany, 30625
        • Chiesi Clinical Trial Site #0301
      • Leipzig, Germany, D-04357
        • Chiesi Clinical Trial Site #0302
  • Italy
      • Ferrara, Italy, 44124
        • Chiesi Clinical Trial Site #0104
      • Napoli, Italy
        • Chiesi Clinical Trial Site #0101
      • Palermo, Italy
        • Scichilone
      • Parma, Italy
        • Chetta
      • Pisa, Italy, 56124
        • Chiesi Clinical Trial Site #0103
      • Verona, Italy, 37134
        • Chiesi Clinical Trial Site #0102
  • Netherlands
      • Alkmaar, Netherlands
        • W. Boersma
      • Groningen, Netherlands
        • Dr. J. Vroegop
      • Groningen, Netherlands
        • Dr. M. vd Berge
      • Hertogenbosch, Netherlands
        • Dr. M. Broeders
  • Spain
      • Barcelona, Spain, 08026
        • Chiesi Clinical Trial Site #0402
      • Lugo, Spain, 27003
        • Chiesi Clinical Trial Site #0401
  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • Chiesi Clinical Trial Site #0503
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Chiesi Clinical Trial Site #0502
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Chiesi Clinical Trial Site #0504
    • Texas
      • Houston, Texas, United States, 77030
        • Chiesi Clinical Trial Site #0501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

900 subjects divided into 800 asthmatic patients and 100 healthy controls will be included. Recruitment will be balanced, at the extent possible, in order to achieve at least > 150 patients each for steps 1 - 4 and > 50 patients for step 5 as indicated in the international guidelines (GINA 2012) on the basis of their previous therapy. The 150 healthy controls will be recruited on the basis of absence of respiratory symptoms, airway obstruction and hyper responsiveness.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Asthmatic patients
asthmatic patients 18 to 65
Healthy volunteers
Volunteers 18 to 65

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the role of small airways abnormalities in the clinical manifestations of asthma.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Dirkje S Postma, Prof. Dr., University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2014

Primary Completion (ACTUAL)

March 4, 2017

Study Completion (ACTUAL)

March 4, 2017

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (ESTIMATE)

April 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-01535AC1-01 (OTHER: Chiesi Farmaceutici)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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