a study to evaluate the effect of dupilumab on exercise capacity in adult patients with asthma

Conditions: Asthma

Summary: the primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma. the secondary objectives of the study are: * to demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma * to demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma


Eligibility criteria:
key inclusion criteria: * a physician diagnosis of asthma * pre-bronchodilator fev1 between 30% and 75% predicted at both the screening and baseline visits * bronchodilator reversibility defined as \>200 ml and 12% increase in fev1 post-administration of a short-acting beta agonist (saba). a patient may also qualify if there is a documented history of bronchodilator reversibility or positive methacholine challenge test within 12 months prior to the screening visit * stable background therapy for at least 3 months with a stable dose ≥4 weeks prior to the baseline visit of a medium-to-high dose ics (fluticasone propionate ≥250 to 1000 μg twice daily \[bid\] or equivalent) in combination with at least a second controller medication (eg, long-acting beta agonist \[laba\], long-acting muscarinic antagonist \[lama\], leukotriene receptor antagonist \[ltra\], theophylline, etc.); a third controller is allowed and with the same stabilization requirements * blood eosinophil count ≥300 cells/μl for patients not on maintenance ocs at the screening visit * acq-5 score ≥1.5 at the screening and baseline visits key exclusion criteria: * body mass index \>35 kg/m2 at screening * current smoking, vaping or tobacco chewing or cessation of any of these within 6 months prior to randomization, or \>10 pack years smoking history * patients who require supplemental oxygen at screening * clinically significant cardiac disease as described in the protocol * uncontrolled hypertension at screening or baseline * participation in exercise or physical rehabilitation program within last 6 months prior to screening or planned during the study * previous use of dupilumab * anti-ige therapy (eg, omalizumab \[xolair®\]) within 130 days prior to visit 1 or any other biologic therapy (including anti-il5, anti-il-5r, anti-il4rα, anti-il-13 mab) or systemic immunosuppressant (eg, methotrexate, any anti-tumor necrosis factor mabs, janus kinase inhibitors, b- and/or t-cell targeted immunosuppressive therapies) to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 3 months or 5 half-lives prior to screening, whichever is longer * exposure to another investigative drug (monoclonal antibodies as well as small molecules) within a period prior to screening, of \<3 months or \<5 half-lives (whichever is longer) * pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study * women of childbearing potential (wocbp)\* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose note: other protocol defined inclusion/exclusion criteria apply