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NCT07245407Fut, nem toboroz

A Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE

A Multi-center Longitudinal Observation Translational Study to Evaluate Phenotypes, Endotypes and Biomarkers in Chinese Patients With NCFBE

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 8.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Non-cystic fibrosis bronchiectasis (NCFBE) is a chronic respiratory disease characterized by a clinical syndrome of chronic productive cough and recurrent respiratory infections in the presence of abnormal and permanent dilation of the bronchi. Recent epidemiological studies have clearly shown that the prevalence and incidence of NCFBE are quickly rising both in high- and low-income countries. With the increase of prevalence, bronchiectasis brings huge medical and economic burden to the society. In this study, the investigator will perform biomarker assessments and multi-omics analysis on NCFBE patients and healthy participants in China to validate the link of disease pathways to pathophysiological features and uncover the molecular endotypes behind clinical phenotypesof Chinese patients with NCFBE.

Állapot (regiszter)
Fut, nem toboroz
Vizsgálattípus
Megfigyeléses
Résztvevők száma
251 (tényleges)
Első benyújtás
2025. szept. 29.
Kezdés
2025. okt. 27.
Elsődleges befejezés
2027. júl. 29.
Fő szponzor
AstraZeneca
NCT-szám
NCT07245407

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 251
  • 2025. okt. 27. és az elsődleges befejezés (2027. júl. 29.) között
  • 38 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Antibiotic treatment for an acute respiratory tract infection in the previous 4 weeks or current sinusitis.
  • Treatment with anti-coagulants.
    • Bronchiectasis cohort:

Más betegség

  • Any respiratory diagnosis (asthma, COPD, bronchiectasis, pulmonary fibrosis or any other chronic respiratory condition requiring regular treatment).
  • Inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, any other connective tissue disease.
  • Active malignancy excluding non-melanoma skin cancer.
  • Traction bronchiectasis associated with interstitial lung disease or other pulmonary disorders (e.g., pulmonary fibrosis and cystic fibrosis).
  • Primary diagnosis of another pulmonary condition, including COPD, asthma. Patients with a secondary diagnosis of these pulmonary diseases will be allowed to participate as long as bronchiectasis is considered by the investigator to be the primary diagnosis.
  • Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
  • The participant has a history of alcohol or drug abuse within the past year, which, in the opinion of the responsible physician, contra-indicates their participation.
  • Active malignancy excluding non-melanoma skin cancer.
  • History or current evidence of an upper or lower respiratory infection or symptoms(including common cold) within 2 weeks of baseline assessments
  • Terminal disease and/or organ failure or participants otherwise considered not appropriate for the study participation.

Egyéb

  • Healthy control cohort:
  • Any contraindication to study procedures including bronchoscopy.
  • Current smoking or smoking in the preceding 3 months.
  • Affect the safety of the participant throughout the study
  • Influence the findings of the study or the interpretation
  • Impede the participant's ability to complete the entire duration of study
  • Participants is female who is pregnant or lactating or up to 6 weeks post-partum or 6 weeks cessation of breastfeeding.
  • The participant has an altered mental status at the time of informed consent.
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study center).

Kiket keres a vizsgálat

  • Healthy control cohort:
  • Age ≥30 years
    • Bronchiectasis cohort:
  • Capable of giving signed informed consent.
  • Participant must be ≥18 years of age, at the time of signing the ICF.
  • Able to perform acceptable lung function testing according to ATS/ERS 2019 acceptability criteria.
  • Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center, and use electronic devices (e.g. FENO and spirometry).
  • Documented physician-diagnosed bronchiectasis: with a clinical history consistent with bronchiectasis (chronic cough and daily sputum production etc.) and having performed chest HRCT indicating bronchiectasis.
  • Remaining clinically stable upon recruitment. Patients with exacerbations are allowed to be enrolled into the study at least 4 weeks after the end of exacerbations. If a patient experiencing exacerbation and directly enters the exacerbation visit, the patient is required to come to the study site for baseline visit (after confirming that all inclusion/exclusion criteria are met) within 4 weeks /+ 3 days after the end of exacerbation

Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (38)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Anning First People's HospitalAnningKínaIsmeretlen állapot
Beijing Chaoyang Hospital affiliated to Capital Medical UniversityBeijingKínaIsmeretlen állapot
Peking University People's HospitalBeijingKínaIsmeretlen állapot
Beijing HospitalBeijingKínaIsmeretlen állapot
The Second Hospital of Jilin UniversityChangchunKínaIsmeretlen állapot
Xiangya Hospital of Central South UniversityChangshaKínaIsmeretlen állapot
West China Hospital of Sichuan UniversityChengduKínaIsmeretlen állapot
Sichuan Academy of Medical Sciences sichuan Provincial People's HospitalChengduKínaIsmeretlen állapot
Chengdu Fifth People's HospitalChengduKínaIsmeretlen állapot
The Second Affiliated Hospital of Chongqing Medical UniversityChongqingKínaIsmeretlen állapot
Guizhou Provincial People's HospitalGuiyangKínaIsmeretlen állapot
The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhouKínaIsmeretlen állapot
Huzhou Central HospitalHuzhouKínaIsmeretlen állapot
Jiaxing First HospitalJiaxingKínaIsmeretlen állapot
Jiaxing Second HospitalJiaxingKínaIsmeretlen állapot
The First Affiliated Hospital of Kunming Medical UniversityKunmingKínaIsmeretlen állapot
Gansu Provincial HospitalLanzhouKínaIsmeretlen állapot
The First Affiliated Hospital of NanChang UniversityNanchangKínaIsmeretlen állapot
The First Affiliated Hospital of Guangxi Medical UniversityNanningKínaIsmeretlen állapot
The First Affiliated Hospital of Ningbo UniversityNingboKínaIsmeretlen állapot
Ningbo Fenghua District People's HospitalNingboKínaIsmeretlen állapot
The Second Affiliated Hospital of Fujian Medical UniversityQuanzhouKínaIsmeretlen állapot
Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghaiKínaIsmeretlen állapot
Shanghai Fifth People's HospitalShanghaiKínaIsmeretlen állapot
Shanghai General HospitalShanghaiKínaIsmeretlen állapot
Shanghai Pulmonary HospitalShanghaiKínaIsmeretlen állapot
Zhongshan Hospital Affiliated to Fudan UniversityShanghaiKínaIsmeretlen állapot
Huadong Hospital Affiliated to Fudan UniversityShanghaiKínaIsmeretlen állapot
Shanghai Tongji HospitalShanghaiKínaIsmeretlen állapot
Shenzhen People's HospitalShenzhenKínaIsmeretlen állapot
Shiyan Taihe HospitalShiyaKínaIsmeretlen állapot
Weifang People's HospitalWeifangKínaIsmeretlen állapot
The First Affiliated Hospital of Wenzhou Medical UniversityWenzhouKínaIsmeretlen állapot
The First Affiliated Hospital of Xinxiang Medical UniversityXinxiangKínaIsmeretlen állapot
The affiliated hospital of xuzhou medical universityXuzhouKínaIsmeretlen állapot
Affiliated Hospital of Guangdong Medical UniversityZhanjiangKínaIsmeretlen állapot
Henan Provincial People's HospitalZhengzhouKínaIsmeretlen állapot
Zhengzhou People's HospitalZhengzhouKínaIsmeretlen állapot

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