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

9 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

1800

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85027
    • California
      • La Palma, California, Förenta staterna, 90623
    • Florida
      • Kissimmee, Florida, Förenta staterna, 34746
      • Miami, Florida, Förenta staterna, 33135
      • Miami, Florida, Förenta staterna, 33182
      • Pembroke Pines, Florida, Förenta staterna, 33026
    • Georgia
      • Adairsville, Georgia, Förenta staterna, 30103
      • Atlanta, Georgia, Förenta staterna, 30344
    • Illinois
      • Champaign, Illinois, Förenta staterna, 61820
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115
      • Worcester, Massachusetts, Förenta staterna, 01655
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63141
    • Pennsylvania
      • DuBois, Pennsylvania, Förenta staterna, 15801
      • Philadelphia, Pennsylvania, Förenta staterna, 19140
    • South Carolina
      • Union, South Carolina, Förenta staterna, 29379
    • Tennessee
      • Franklin, Tennessee, Förenta staterna, 37067
    • Texas
      • Houston, Texas, Förenta staterna, 77008
  • Italien
      • Milan, Italien, 20157
      • Milan, Italien, 20122
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Kontakt:
      • Naples, Italien, 80131
        • Azienda Ospedaliera Universitaria "Federico II"
        • Kontakt:
      • Roma, Italien, 00133
  • Malaysia
      • Kajang, Malaysia, 43000
      • Kelantan, Malaysia, 15586
      • Kuala Lumpur, Malaysia, 59100
      • Kuala Lumpur, Malaysia, 53000

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebogrupp
Läkemedel: Placebo matching verducatib

Placebo matching verducatib
Experimentell: Verducatib treatment group
Läkemedel: Verducatib

Verducatib

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to first moderate or severe AECOPD
Tidsram: Up to week 76
Up to week 76
Time to first severe AECOPD
Tidsram: 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
Tidsram: 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
Tidsram: At baseline and at week 52
At baseline and at week 52
Annualised rate of severe AECOPD
Tidsram: Up to week 76
Up to week 76
Absolute change from baseline in SGRQ total score at week 52
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: At baseline and at week 52
At baseline and at week 52

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 mars 2027

Primärt slutförande (Beräknad)

12 november 2029

Avslutad studie (Beräknad)

10 december 2029

Studieregistreringsdatum

Först inskickad

23 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

26 oktober 2026

Första postat (Faktisk)

30 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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