Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design
Background Many patients with asthma experience loss of lung function over time, and in certain patients this can lead to progressive obstructive patterns similar to COPD. Patients with severe asthma may experience accelerated lung function decline (LFD). However, characteristics and risk factors fo...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
European Respiratory Society
2023-03-01
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| Series: | ERJ Open Research |
| Online Access: | http://openres.ersjournals.com/content/9/2/00417-2022.full |
| _version_ | 1827931425147453440 |
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| author | Lucia De Prado Gomez Ian Pavord William Busse Christopher E. Brightling Michael E. Wechsler Klaus F. Rabe Mei Zhang Jun Xing Juby A. Jacob-Nara Paul J. Rowe |
| author_facet | Lucia De Prado Gomez Ian Pavord William Busse Christopher E. Brightling Michael E. Wechsler Klaus F. Rabe Mei Zhang Jun Xing Juby A. Jacob-Nara Paul J. Rowe |
| author_sort | Lucia De Prado Gomez |
| collection | DOAJ |
| description | Background
Many patients with asthma experience loss of lung function over time, and in certain patients this can lead to progressive obstructive patterns similar to COPD. Patients with severe asthma may experience accelerated lung function decline (LFD). However, characteristics and risk factors for LFD in asthma have not been well described. Dupilumab may prevent or slow the rate of LFD in patients with uncontrolled, moderate-to-severe asthma. ATLAS trial is designed to evaluate the role of dupilumab in preventing/slowing LFD over a period of 3 years versus standard-of-care therapy.
Methods
ATLAS (clinicaltrials.gov identifier NCT05097287) is a randomised, double-blind, placebo-controlled, multicentre study that will include adult patients with uncontrolled moderate-to-severe asthma. ∼1828 patients will be randomised (2:1) to dupilumab 300 mg or placebo in combination with maintenance therapy every 2 weeks for 3 years. The primary objective is to assess the effect of dupilumab on preventing or slowing LFD by year 1 in the exhaled nitric oxide fraction (FeNO) population (patients with FeNO ≥35 ppb). The effect of dupilumab in slowing the rate of LFD by year 2 and year 3 in both FeNO and total populations, exacerbations, asthma control, quality of life, biomarker changes and utility of FeNO as a biomarker of LFD will also be evaluated.
Discussion
ATLAS is the first trial assessing the effect of a biologic on LFD, designed to establish the role of dupilumab in prevention of long-term loss of lung function and its potential effect on disease modification, which may provide unique insights into asthma pathophysiology, including predictive and prognostic factors of LFD. |
| first_indexed | 2024-03-13T06:52:27Z |
| format | Article |
| id | doaj.art-29665b18d99e4e989031208479d20f81 |
| institution | Directory Open Access Journal |
| issn | 2312-0541 |
| language | English |
| last_indexed | 2024-03-13T06:52:27Z |
| publishDate | 2023-03-01 |
| publisher | European Respiratory Society |
| record_format | Article |
| series | ERJ Open Research |
| spelling | doaj.art-29665b18d99e4e989031208479d20f812023-06-07T13:31:07ZengEuropean Respiratory SocietyERJ Open Research2312-05412023-03-019210.1183/23120541.00417-202200417-2022Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial designLucia De Prado Gomez0Ian Pavord1William Busse2Christopher E. Brightling3Michael E. Wechsler4Klaus F. Rabe5Mei Zhang6Jun Xing7Juby A. Jacob-Nara8Paul J. Rowe9 Sanofi, Reading, UK NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK UW Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA Institute for Lung Health, NIHR Leicester Biomedical Research Center, Department of Respiratory Sciences, University of Leicester, Leicester, UK National Jewish Health, Denver, CO, USA LungenClinic Grosshansdorf (member of the German Center for Lung Research (DZL)), Airway Research Center North (ARCN), Grosshansdorf, Germany Sanofi, Bridgewater, NJ, USA Sanofi, Bridgewater, NJ, USA Sanofi, Bridgewater, NJ, USA Sanofi, Bridgewater, NJ, USA Background Many patients with asthma experience loss of lung function over time, and in certain patients this can lead to progressive obstructive patterns similar to COPD. Patients with severe asthma may experience accelerated lung function decline (LFD). However, characteristics and risk factors for LFD in asthma have not been well described. Dupilumab may prevent or slow the rate of LFD in patients with uncontrolled, moderate-to-severe asthma. ATLAS trial is designed to evaluate the role of dupilumab in preventing/slowing LFD over a period of 3 years versus standard-of-care therapy. Methods ATLAS (clinicaltrials.gov identifier NCT05097287) is a randomised, double-blind, placebo-controlled, multicentre study that will include adult patients with uncontrolled moderate-to-severe asthma. ∼1828 patients will be randomised (2:1) to dupilumab 300 mg or placebo in combination with maintenance therapy every 2 weeks for 3 years. The primary objective is to assess the effect of dupilumab on preventing or slowing LFD by year 1 in the exhaled nitric oxide fraction (FeNO) population (patients with FeNO ≥35 ppb). The effect of dupilumab in slowing the rate of LFD by year 2 and year 3 in both FeNO and total populations, exacerbations, asthma control, quality of life, biomarker changes and utility of FeNO as a biomarker of LFD will also be evaluated. Discussion ATLAS is the first trial assessing the effect of a biologic on LFD, designed to establish the role of dupilumab in prevention of long-term loss of lung function and its potential effect on disease modification, which may provide unique insights into asthma pathophysiology, including predictive and prognostic factors of LFD.http://openres.ersjournals.com/content/9/2/00417-2022.full |
| spellingShingle | Lucia De Prado Gomez Ian Pavord William Busse Christopher E. Brightling Michael E. Wechsler Klaus F. Rabe Mei Zhang Jun Xing Juby A. Jacob-Nara Paul J. Rowe Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design ERJ Open Research |
| title | Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design |
| title_full | Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design |
| title_fullStr | Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design |
| title_full_unstemmed | Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design |
| title_short | Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design |
| title_sort | long term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate to severe asthma atlas trial design |
| url | http://openres.ersjournals.com/content/9/2/00417-2022.full |
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