AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

Asthma Clinical Trial

— ATLANTIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123667
• Other study ID #: CCD-01535AC1-01
• Secondary ID: CCD-01535AC1-01
• Status: Completed
• Start date: June 30, 2014
• Est. completion date: March 4, 2017

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Large non pharmacological studies on Small Airways Disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 872
• Est. completion date: March 4, 2017
• Est. primary completion date: March 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?FEV1 = 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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Brazil	Prof. Dr. Emilio Pizzichini	Florianópolis
Brazil	Prof. Dr. Alberto Cukier	São Paulo
Brazil	Prof. Dr. Rafael Stelmach	São Paulo
Canada	Chiesi Clinical Trial Site #0201	Montreal	Quebec
China	Gao	Beijing	Beijing
China	Qingling Zhang	Hangzhou
China	Yuanlin Song	Shanghai	Shanghai
Germany	Chiesi Clinical Trial Site #0303	Grosshansdorf
Germany	Chiesi Clinical Trial Site #0301	Hannover
Germany	Chiesi Clinical Trial Site #0302	Leipzig
Italy	Chiesi Clinical Trial Site #0104	Ferrara
Italy	Chiesi Clinical Trial Site #0101	Napoli
Italy	Scichilone	Palermo
Italy	Chetta	Parma
Italy	Chiesi Clinical Trial Site #0103	Pisa
Italy	Chiesi Clinical Trial Site #0102	Verona
Netherlands	W. Boersma	Alkmaar
Netherlands	Dr. J. Vroegop	Groningen
Netherlands	Dr. M. vd Berge	Groningen
Netherlands	Dr. M. Broeders	Hertogenbosch
Spain	Chiesi Clinical Trial Site #0402	Barcelona
Spain	Chiesi Clinical Trial Site #0401	Lugo
United States	Chiesi Clinical Trial Site #0504	Cleveland	Ohio
United States	Chiesi Clinical Trial Site #0503	Denver	Colorado
United States	Chiesi Clinical Trial Site #0502	Durham	North Carolina
United States	Chiesi Clinical Trial Site #0501	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

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

References & Publications (1)

Postma DS, Brightling C, Baldi S, Van den Berge M, Fabbri LM, Gagnatelli A, Papi A, Van der Molen T, Rabe KF, Siddiqui S, Singh D, Nicolini G, Kraft M; ATLANTIS study group. Exploring the relevance and extent of small airways dysfunction in asthma (ATLANT — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the role of small airways abnormalities in the clinical manifestations of asthma.		1 year