A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation - BOREAS

Sanofi-aventis Recherche & Développement0 sites2,054 target enrollmentMarch 14, 2022

Overview

No summary available.

Registry

who.int

Start Date

March 14, 2022

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-Participants with a physician diagnosis of COPD who meet the following criteria:
•\-Current or former smokers with a smoking history of \=10 pack\-years.
•\-Moderate\-to\-severe COPD (post\-bronchodilator FEV1/ forced vital capacity \[FVC] \=70% and post\-bronchodilator FEV1 % predicted \>30% and \=70%).
•\-Medical Research Council (MRC) Dyspnea Scale grade \=2\.
•\-Patient\-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
•\-Documented history of high exacerbation risk defined as exacerbation history of \=2 moderate or \=1 severe within the year prior to inclusion.
•Moderate exacerbations are recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteriods.
•Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization/emergency room
•visit or result in death.
•\-Background triple therapy (inhaled corticosteroid \[ICS] \+ long acting beta agonist \[LABA] \+ long acting muscarinic agonist \[LAMA]) for 3 months prior to randomization with a stable dose of medication for \=1 month prior to Visit 1; Double therapy (LABA \+ LAMA) allowed if ICS is contraindicated.

•\- COPD diagnosis for less than 12 months prior to randomization.
•\- A current diagnosis of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines; or a history of asthma with age of onset \= 40 years of age.
•\- Significant pulmonary disease other than COPD (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg\-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
•\- Cor pulmonale, evidence of right cardiac failure.
•\- Treatment with oxygen of more than 12 hours per day.
•\- Hypercapnia requiring Bi\-level ventilation.
•\- AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.
•\- Respiratory tract infection within 4 weeks prior to screening, or during the screening period.
•\- History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation \<4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included).
•\- Diagnosis of a\-1 anti\-trypsin deficiency.