Clinical trial NCT02123667: AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)
Official title: AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS); Multinational, Multicentre, Non-pharmacological Intervention, Cross-sectional and Longitudinal Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2014-04-25
Enrollment: 872
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: Large non pharmacological studies on Small Airways Disease

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.

Primary outcomes:
measure: To determine the role of small airways abnormalities in the clinical manifestations of asthma.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Chiesi Clinical Trial Site #0503
state: Colorado
city: Durham
country: United States
facility: Chiesi Clinical Trial Site #0502
state: North Carolina
city: Cleveland
country: United States
facility: Chiesi Clinical Trial Site #0504
state: Ohio
city: Houston
country: United States
facility: Chiesi Clinical Trial Site #0501
state: Texas
city: Florianópolis
country: Brazil
facility: Prof. Dr. Emilio Pizzichini
city: São Paulo
country: Brazil
facility: Prof. Dr. Alberto Cukier
city: São Paulo
country: Brazil
facility: Prof. Dr. Rafael Stelmach
city: Montreal
country: Canada
facility: Chiesi Clinical Trial Site #0201
state: Quebec
city: Beijing
country: China
facility: Gao
state: Beijing
city: Shanghai
country: China
facility: Yuanlin Song
state: Shanghai
city: Hangzhou
country: China
facility: Qingling Zhang
city: Grosshansdorf
country: Germany
facility: Chiesi Clinical Trial Site #0303
city: Hannover
country: Germany
facility: Chiesi Clinical Trial Site #0301
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial Site #0302
city: Ferrara
country: Italy
facility: Chiesi Clinical Trial Site #0104
city: Napoli
country: Italy
facility: Chiesi Clinical Trial Site #0101
city: Palermo
country: Italy
facility: Scichilone
city: Parma
country: Italy
facility: Chetta
city: Pisa
country: Italy
facility: Chiesi Clinical Trial Site #0103
city: Verona
country: Italy
facility: Chiesi Clinical Trial Site #0102
city: Alkmaar
country: Netherlands
facility: W. Boersma
city: Groningen
country: Netherlands
facility: Dr. J. Vroegop
city: Groningen
country: Netherlands
facility: Dr. M. vd Berge
city: Hertogenbosch
country: Netherlands
facility: Dr. M. Broeders
city: Barcelona
country: Spain
facility: Chiesi Clinical Trial Site #0402
city: Lugo
country: Spain
facility: Chiesi Clinical Trial Site #0401
Study officials:
affiliation: Duke University
name: Monica Kraft, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Dirkje S Postma, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 (ATLANTIS): baseline data from a prospective cohort study. Lancet Respir Med. 2019 May;7(5):402-416. doi: 10.1016/S2213-2600(19)30049-9. Epub 2019 Mar 12.