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The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease

9 novembre 2026 mis à jour par: Boehringer Ingelheim

The AIRWARD Study: A Phase III, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate the Efficacy and Safety of Verducatib in Participants With COPD

This study is open to adults aged 40 years and older who have chronic obstructive pulmonary disease (COPD) with ongoing symptoms. People can join the study if they are at risk of COPD flare-ups (also called acute exacerbations or sudden worsening of COPD symptoms) even though they use their usual inhaled or oral COPD medicines. They must have had at least 2 moderate COPD flare-ups or at least 1 severe COPD flare-up in the past year, including at least 1 while taking their current COPD treatment. People must also have a blood test result showing less than 300 eosinophils (a type of white blood cell) per microliter. The purpose of this study is to find out whether a medicine called verducatib helps people with COPD have fewer flare-ups or sudden worsening of COPD symptoms over up to about 1.5 years, compared with placebo. The study also looks at whether verducatib delays the time until the first flare-up, how well it is tolerated, improves participants' quality of life, and improves their lung function when compared with placebo.

In this study, participants are put into 2 groups randomly, which means by chance. One group takes verducatib as tablets and the other group takes placebo tablets. Placebo tablets look like verducatib tablets but do not contain any medicine. Participants take a tablet by mouth once a day for at least 1 year and up to about 1.5 years. All participants continue their regular COPD treatment during the study.

Participants are in the study for at least 1 year and up to about 1 year and 8 months. During this time, they have regular visits at the study site and monthly phone calls from the study staff to check on their COPD symptoms and any health problems. Doctors collect information about participants' health, including blood samples. They record how often participants have moderate or severe COPD flare-ups and how long it takes until the first flare-up. They also measure lung function and ask participants to fill in questionnaires about their symptoms and daily life. Participants have to daily report their symptoms and intake of certain medications in an electronic diary at home. The results are compared between the 2 groups to see whether verducatib helps reduce flare-ups and improves symptoms. The doctors also regularly check participants' health and note any unwanted effects.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

1800

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Italie
      • Milan, Italie, 20157
        • ASST Fatebenefratelli Sacco
        • Contact:
      • Milan, Italie, 20122
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Contact:
      • Naples, Italie, 80131
        • Azienda Ospedaliera Universitaria "Federico II"
        • Contact:
      • Roma, Italie, 00133
        • Pol. Universitario Tor Vergata
        • Contact:
  • Malaisie
      • Kajang, Malaisie, 43000
        • Hospital Sultan Idris Shah Serdang
        • Contact:
      • Kelantan, Malaisie, 15586
        • Hospital Raja Perempuan Zainab II
        • Contact:
      • Kuala Lumpur, Malaisie, 59100
        • University Malaya Medical Centre
        • Contact:
      • Kuala Lumpur, Malaisie, 53000
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
    • Arizona
      • Phoenix, Arizona, États-Unis, 85027
    • California
      • La Palma, California, États-Unis, 90623
    • Florida
      • Kissimmee, Florida, États-Unis, 34746
      • Miami, Florida, États-Unis, 33135
      • Miami, Florida, États-Unis, 33182
      • Pembroke Pines, Florida, États-Unis, 33026
    • Georgia
      • Adairsville, Georgia, États-Unis, 30103
      • Atlanta, Georgia, États-Unis, 30344
    • Illinois
      • Champaign, Illinois, États-Unis, 61820
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
      • Worcester, Massachusetts, États-Unis, 01655
    • Missouri
      • St Louis, Missouri, États-Unis, 63141
    • Pennsylvania
      • DuBois, Pennsylvania, États-Unis, 15801
      • Philadelphia, Pennsylvania, États-Unis, 19140
    • South Carolina
      • Union, South Carolina, États-Unis, 29379
    • Tennessee
      • Franklin, Tennessee, États-Unis, 37067
        • Clinical Trials Center of Middle Tennessee, LLC
        • Contact:
    • Texas
      • Houston, Texas, États-Unis, 77008
        • Greater Heights & Memorial Pulmonary and Sleep
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Age ≥40 years

  • Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months prior to screening according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) definition

  • Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)/forced vital capacity [FVC] <0.70 at screening and baseline

  • Post-BD forced expiratory volume in 1 second percent predicted (FEV1pp) ≥30% at screening

  • Current or former cigarette smokers with a smoking history ≥10 pack years history of cigarette smoking

  • Chronic Airways Disease Assessment Test (CAAT) score ≥10 at screening with cough and sputum sub-scores of ≥ 2

  • Documented history of ≥2 moderate or ≥1 severe exacerbations within 12 months prior to screening. At least one exacerbation must have occurred while participants were on their current COPD maintenance therapy

  • Stable standard of care considered appropriate by the investigator for at least 3 months prior to screening with either

    • Triple therapy Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) + Inhaled corticosteroid (ICS)
    • Double therapy LAMA+LABA Additional medications, e.g. as per local COPD guidelines should also be stable for at least 3 months

  • Blood eosinophil count <300 cells/µL at screening Further inclusion criteria apply.

Exclusion Criteria:

  • Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18
  • Clinically significant pulmonary disease other than COPD, e.g. sarcoidosis, interstitial lung disease, alpha-1 antitrypsin deficiency
  • Past or current diagnosis of bronchiectasis or bronchiectasis-COPD overlap as assessed by the investigator
  • estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula <30 mL/min at screening
  • Upper and lower respiratory tract infection within 4 weeks prior to screening or during the screening and randomisation period
  • Participants with bronchoscopic interventional procedures up to 3 years prior to screening
  • Prior history of or planned pneumonectomy or lung volume reduction surgery.
  • Participants who are participating in the acute phase of a pulmonary rehabilitation or smoking-cessation program, i.e. who started such program < 4 weeks prior screening
  • Moderate or severe Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 4 weeks prior to screening or between screening and randomisation Further exclusion criteria apply.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Groupe placebo
Médicament: Placebo matching verducatib

Placebo matching verducatib
Expérimental: Verducatib treatment group
Médicament: Verducatib

Verducatib

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Annualised rate of moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (number of events per person per year)
Délai: Up to week 76
Up to week 76

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time to first moderate or severe AECOPD
Délai: Up to week 76
Up to week 76
Time to first severe AECOPD
Délai: Up to week 76
Up to week 76
Achievement of St George's Respiratory Questionnaire (SGRQ) response (decrease in total score by ≥4 points from baseline) at week 52
Délai: At baseline and at week 52

SGRQ consists of 50 items covering symptoms, activity and impacts on daily life with varying response options (3 to 5-point Likert scales, dichotomous response option). Domain scores as well as a global score are generated ranging from 0 to 100, with lower scores indicating better health related Quality of Life (QoL).
At baseline and at week 52
Absolute change from baseline in post-Bronchodilator (BD) forced expiratory volume in 1 second (FEV1) (milliliters) at week 52
Délai: At baseline and at week 52
At baseline and at week 52
Annualised rate of severe AECOPD
Délai: Up to week 76
Up to week 76
Absolute change from baseline in SGRQ total score at week 52
Délai: At baseline and at week 52
At baseline and at week 52
Achievement of Evaluating Respiratory Symptoms E-RS: COPD response (decrease by ≥2 points from baseline) at week 52
Délai: At baseline and at week 52

E-RS:COPD is an 11-item respiratory symptom score derived from the 14-item Exacerbations of chronic pulmonary disease tool (EXACT)-COPD diary and is used to assess the severity of daily respiratory symptoms in patients with stable COPD. It covers exacerbation-related symptoms breathlessness (5 items), cough and sputum (3 items), and chest symptoms (3 items). These items sum up to a total score ranging from 0 to 40, with higher scores indicating higher symptom severity.
At baseline and at week 52
Achievement of Chronic Airways Disease Assessment Test (CAAT) response (decrease by ≥2 points from baseline) at week 52
Délai: At baseline and at week 52

CAAT is designed to measure health status impairment in chronic airways disease; it consists of 8 unidimensional items with scores ranging from 0 to 5 (0 = no impairment). The total score ranges from 0 - 40 with a higher score indicating a worse health status of the patient.
At baseline and at week 52
Absolute change from baseline in post-BD Forced expiratory volume in 1 second percent predicted (FEV1pp) at week 52
Délai: At baseline and at week 52
At baseline and at week 52

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boehringer Ingelheim

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 mars 2027

Achèvement primaire (Estimé)

12 novembre 2029

Achèvement de l'étude (Estimé)

10 décembre 2029

Dates d'inscription aux études

Première soumission

23 octobre 2026

Première soumission répondant aux critères de contrôle qualité

26 octobre 2026

Première publication (Réel)

30 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1397-0047
  • 2026-527805-39-00 (Identificateur de registre: CTIS (EU))
  • U1111-1345-6424 (Identificateur de registre: WHO International Clinical Trials Registry Platform (ICTRP))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.

Délai de partage IPD

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

Critères d'accès au partage IPD

For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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