NOTUS
Research type
Research Study
Full title
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
IRAS ID
279785
Contact name
Anita Pichori
Contact email
Eudract number
2018-001954-91
Clinicaltrials.gov Identifier
RESP43895, CRN
Duration of Study in the UK
2 years, 11 months, 26 days
Research summary
The purpose of the study is to evaluate how effective dupilumab is and how safe it is in reducing the signs and symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD) who have a high level of blood eosinophils and are in need of additional treatment.
COPD is a highly prevalent disease, associated with significant economic burden, and for which available standard-of-care therapies show insufficient treatment effect on symptoms, lung function, exacerbations and long-term progression of the disease.
Although the inflammatory component in COPD is typically thought to be neutrophils, a subgroup of COPD patients have been identified who have a high level of blood eosinophils therefore suggesting a Type 2 inflammatory component of the disease.
The study is a randomised, double blind, placebo-controlled study and is planned to include approximately 924 participants. Each participant will be involved in the study for approximately 68 weeks and will attend approximately 19 visits to the research site. All participants will receive standard of care background medication throughout the study. Most participants will be expected to administer study drug at home between study visits.REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0812
Date of REC Opinion
23 Jun 2020
REC opinion
Further Information Favourable Opinion