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Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle
Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle

NCT06646419

Active Not RecruitingN/A

Sponsor: AstraZeneca

Conditions: COPD

Countries: China

This is a cluster randomized interventional study. Intervention is implemented at a hospital level and will change overall daily practice. 36 county level hospitals are r an domized to the intervention group or control group at the ratio of 2:1 . Total subjects is 1368 and a size of 38 per hospital .

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Diagnosed COPD (post- bronchodilator FEV1/FVC \< 0.7)
* 40\~80 years
* CAT≥10
* At least two moderate or at least one severe exacerbation history in past 1 year
* Able to sign informed consent

Exclusion Criteria:

* Continuous triple inhalation therapy for ≥6 months at baseline (include single inhaler and multiple inhalers)
* Stable COPD (symptom such as cough, sputum and shortness of breath are mild or stable, clinical condition has basically returned to pre-exacerbation)
* Comorbidities require/contraindicate long-term use of glucocorticoid treatment: asthma, interstitial lung disease, sarcoidosis, cystic fibrosis, active tuberculosis recurrent aspiration pneumonia ect.
* Serious comorbidities threaten to life expected survival time no more than 1 year: severe heart disease, severe chronic liver, severe kidney disease, cerebrovascular disease with long-term bed rest and malignant tumours ect.
* Not living in the healthcare area
* Patients currently participating in any other interventional studies
Locations (37)
  • Anyang, China
  • Baise City, China
  • Beijing, China
  • Bijie, China
  • Changsha, China
  • Chenzhou, China
  • Chifeng, China
  • Chuzhou, China
  • Deyang, China
  • Fuyang, China
  • Hangzhou, China
  • Hefei, China
  • Jieyang, China
  • Jining, China
  • Jiujiang, China
  • Kaiyuan, China
  • Langfang, China
  • Langzhong, China
  • Leping, China
  • Nanchang, China
  • Nanchong, China
  • Neijiang, China
  • Qiannan, China
  • Qujing, China
  • Sanmenxia, China
  • Shaoyang, China
  • Suzhou, China
  • Tengzhou, China
  • Tieling, China
  • Wenzhou, China
  • + 7 more on CT.gov