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

2026년 11월 9일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

1800

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 말레이시아
      • Kajang, 말레이시아, 43000
        • Hospital Sultan Idris Shah Serdang
        • 연락하다:
      • Kelantan, 말레이시아, 15586
      • Kuala Lumpur, 말레이시아, 59100
      • Kuala Lumpur, 말레이시아, 53000
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35233
    • Arizona
      • Phoenix, Arizona, 미국, 85027
    • California
      • La Palma, California, 미국, 90623
    • Florida
      • Kissimmee, Florida, 미국, 34746
      • Miami, Florida, 미국, 33135
      • Miami, Florida, 미국, 33182
      • Pembroke Pines, Florida, 미국, 33026
    • Georgia
      • Adairsville, Georgia, 미국, 30103
      • Atlanta, Georgia, 미국, 30344
    • Illinois
      • Champaign, Illinois, 미국, 61820
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
      • Worcester, Massachusetts, 미국, 01655
    • Missouri
      • St Louis, Missouri, 미국, 63141
    • Pennsylvania
      • DuBois, Pennsylvania, 미국, 15801
      • Philadelphia, Pennsylvania, 미국, 19140
    • South Carolina
      • Union, South Carolina, 미국, 29379
    • Tennessee
      • Franklin, Tennessee, 미국, 37067
    • Texas
      • Houston, Texas, 미국, 77008
  • 이탈리아
      • Milan, 이탈리아, 20157
        • ASST Fatebenefratelli Sacco
        • 연락하다:
      • Milan, 이탈리아, 20122
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • 연락하다:
      • Naples, 이탈리아, 80131
        • Azienda Ospedaliera Universitaria "Federico II"
        • 연락하다:
      • Roma, 이탈리아, 00133
        • Pol. Universitario Tor Vergata
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약 그룹
의약품: Placebo matching verducatib

Placebo matching verducatib
실험적: Verducatib treatment group
의약품: Verducatib

Verducatib

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

결과 측정
측정값 설명
기간
Time to first moderate or severe AECOPD
기간: Up to week 76
Up to week 76
Time to first severe AECOPD
기간: 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
기간: 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
기간: At baseline and at week 52
At baseline and at week 52
Annualised rate of severe AECOPD
기간: Up to week 76
Up to week 76
Absolute change from baseline in SGRQ total score at week 52
기간: 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
기간: 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
기간: 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
기간: At baseline and at week 52
At baseline and at week 52

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 3월 10일

기본 완료 (추정된)

2029년 11월 12일

연구 완료 (추정된)

2029년 12월 10일

연구 등록 날짜

최초 제출

2026년 10월 23일

QC 기준을 충족하는 최초 제출

2026년 10월 26일

처음 게시됨 (실제)

2026년 10월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 9일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

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.

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다