Pivotal study to assess the efficacy, safety and tolerability of dupilumab in patients with moderate-to-severe COPD with Type 2 inflammation (BOREAS)

Phase 1

Active, not recruiting

• Conditions: Chronic obstructive pulmonary disease; MedDRA version: 21.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001953-28-IT
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-13
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3080

Inclusion Criteria

-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] 30% and -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. taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic agonist (LAMA) (or LABA/LAMA if ICS is contraindicated).
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 treatment for >24 hours in emergency department/urgent care facility 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.
-Evidence of Type 2 inflammation: Patients with blood eosinophils >/=300 cells/microliter at Visit 1..
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2381
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 699

Exclusion Criteria

- COPD diagnosis for less than 12 months prior to randomization.
- A current diagnosis of asthma or history 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 alfa-1 anti-trypsin deficiency..

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified