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RecruitingPhase 4

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 40 weeks, 24 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study details include: The study duration will be up to 40 weeks."
  • "The treatment duration will be up to 24 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests dupilumab shots under the skin against a placebo (a shot with no active drug) in adults ages 40 to 85 with COPD, a long-term lung disease. It looks at swelling, blockage, and changes in the airways, and how these relate to breathing, flare-ups, and quality of life. The study lasts up to 40 weeks, with treatment for up to 24 weeks and 9 visits.

LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 40 to 85 with COPD diagnosed by a doctor.
  • Currently smoke or used to smoke, with at least 10 pack-years of smoking (such as 1 pack a day for 10 years).
  • Have moderate-to-severe COPD based on breathing tests.
  • Have a breathlessness score of at least 2 or a COPD symptom score of at least 10.
  • Have frequent or severe COPD flare-ups.
  • Have used three types of COPD medicines (ICS, LABA, and LAMA) for 3 months before treatment assignment, with no dose change for at least 1 month before the first visit. Two types (LABA and LAMA) are allowed if ICS is not safe for you.
  • Have high levels of eosinophils, a type of white blood cell: at least 300 cells/μL at screening, or at least 150 at screening plus a level of at least 300 in the past year when not having a flare-up.
  • Have a mucus blockage score of at least 3.

Who can't join

  • Have asthma now or a recorded history of asthma.
  • Have another major lung disease, or another disease linked to high eosinophil levels.
  • Use oxygen at more than 4 liters per minute for at least 8 hours a day.
  • Have an airway or lung infection within 4 weeks before screening or during screening.
  • Have alpha-1 antitrypsin deficiency, a condition involving a protein that protects the lungs.
  • Receive any biologic medicine, including experimental treatments or dupilumab.
  • Take mucus-thinning medicines unless treatment has been stable for more than 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening: * Current or former smokers with a smoking history of ≥10 pack-years * Moderate-to-severe COPD (post-BD FEV1/FVC ratio \<0.70 and post-BD FEV1 % predicted \>30% and ≤70%) * Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10 * Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations * Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated * Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation). * Mucus score cutoff of ≥3 Exclusion Criteria: * A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma * Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts * Treatment with oxygen \>4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period * Diagnosis of α-1 anti-trypsin deficiency * Any biologic therapy (including experimental treatments and dupilumab) * Participants on treatment with mucolytics unless on stable therapy for \>6 months The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study sites (11)

AL

  • University of Alabama at Birmingham - School of Medicine- Site Number : 8400003 · Birmingham, AL 35233More trials in Birmingham

FL

GA

KS

MA

MD

NC

PA

  • Clinical Research Associates of Central Pennsylvania- Site Number : 8400002 · DuBois, PA 15801More trials in DuBois

TX