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

Phase 1

• 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-RO
• Lead Sponsor: Sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-14
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2054

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] =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.
-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 1588
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 466

Exclusion Criteria

- 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.

Study & Design

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