--- title: Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle nct_id: NCT06646419 overall_status: ACTIVE_NOT_RECRUITING sponsor: AstraZeneca study_type: OBSERVATIONAL primary_condition: COPD countries: China canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06646419.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06646419" ct_last_update_post_date: 2026-02-20 last_seen_at: "2026-05-12T07:17:15.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle **Official Title:** Boosting Regional Integration for COPD Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle: A Multicentre , Prospective, Cluster Randomization, Inteventional Clinical Study **NCT ID:** [NCT06646419](https://clinicaltrials.gov/study/NCT06646419) ## Key Facts - **Status:** ACTIVE_NOT_RECRUITING - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 1368 - **Lead Sponsor:** AstraZeneca - **Conditions:** COPD - **Start Date:** 2024-11-13 - **Completion Date:** 2026-08-31 - **CT.gov Last Update:** 2026-02-20 ## Brief Summary 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 . ## Detailed Description The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit. Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks.Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.The control group will maintain the current usual care practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks. Eligible consented patients will be enrolled consecutively to minimize selection bias. In order to achieve the purpose of continuous enrollment, all patients who visit the outpatient clinic,emergency room, and hospitalized due to exacerbation of COPD will be screened, including newly diagnosed patients or those who have bee n treated. ## Eligibility - **Minimum age:** 40 Years - **Maximum age:** 80 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Intervention group** — Intervention is implemented at a hospital level and will change overall daily practice. The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks. Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks. - **Control group** — The control group will maintain the current usual care practice. ## Primary Outcomes - **Time to CID.** _(time frame: week0-week48)_ — To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID). ## Secondary Outcomes - **Proportion of patients received long-acting maintenance inhalation with the percentage of days covered (PDC) ≥70%.** _(time frame: week 12, 24, 36 and 48)_ - **Inhalation therapy consistency rate with guideline.** _(time frame: week 12, 24, 36 and 48)_ - **Inhaler device compliance,measured by the score of Test of the adherence to inhalers( TAI ) questionnare.** _(time frame: week 24 and 48)_ - **Correct operation rate of inhalation device.** _(time frame: week 24 and 48)_ - **Patient satisfaction rate with treatment.** _(time frame: week 24 and 48)_ - **Disease knowledge score of patients.** _(time frame: week 24 and 48)_ - **Proportion of patients received different categories of long-acting maintenance inhalation.** _(time frame: week 12, 24,36 and 48)_ - **Rate of moderate or severe exacerbation.** _(time frame: week 12, 24 and 48)_ - **Rate of severe exacerbation.** _(time frame: week 12, 24 and 48)_ - **Rate of cardiovascular events.** _(time frame: week 12, 24 and 48)_ - **Change of CAT score.** _(time frame: week 0 to week 48)_ - **Percentage change of trough FEV1 and MMEF.** _(time frame: week 0 to week 48)_ ## Locations (37) - Research Site, Anyang, China - Research Site, Baise City, China - Research Site, Beijing, China - Research Site, Bijie, China - Research Site, Changsha, China - Research Site, Chenzhou, China - Research Site, Chifeng, China - Research Site, Chuzhou, China - Research Site, Deyang, China - Research Site, Fuyang, China - Research Site, Hangzhou, China - Research Site, Hefei, China - Research Site, Jieyang, China - Research Site, Jining, China - Research Site, Jiujiang, China - Research Site, Kaiyuan, China - Research Site, Langfang, China - Research Site, Langzhong, China - Research Site, Leping, China - Research Site, Nanchang, China - Research Site, Nanchong, China - Research Site, Neijiang, China - Research Site, Qiannan, China - Research Site, Qujing, China - Research Site, Sanmenxia, China - Research Site, Shaoyang, China - Research Site, Suzhou, China - Research Site, Tengzhou, China - Research Site, Tieling, China - Research Site, Wenzhou, China - Research Site, Xiangtan, China - Research Site, Xiaogan, China - Research Site, Xinyang, China - Research Site, Yancheng, China - Research Site, Yichang, China - Research Site, Yuling, China - Research Site, Zaoyang, China ## Recent Field Changes (last 30 days) - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.research site|hefei||china` — added _(2026-05-12)_ - `locations.research site|jieyang||china` — added _(2026-05-12)_ - `locations.research site|jining||china` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.research site|anyang||china` — added _(2026-05-12)_ - `locations.research site|baise city||china` — added _(2026-05-12)_ - `locations.research site|beijing||china` — added _(2026-05-12)_ - `locations.research site|bijie||china` — added _(2026-05-12)_ - `locations.research site|changsha||china` — added _(2026-05-12)_ - `locations.research site|chenzhou||china` — added _(2026-05-12)_ - `locations.research site|chifeng||china` — added _(2026-05-12)_ - `locations.research site|chuzhou||china` — added _(2026-05-12)_ - `locations.research site|deyang||china` — added _(2026-05-12)_ - `locations.research site|fuyang||china` — added _(2026-05-12)_ - `locations.research site|hangzhou||china` — added _(2026-05-12)_ - `locations.research site|jiujiang||china` — added _(2026-05-12)_ - `locations.research site|kaiyuan||china` — added _(2026-05-12)_ - `locations.research site|langfang||china` — added _(2026-05-12)_ - `locations.research site|langzhong||china` — added _(2026-05-12)_ - `locations.research site|leping||china` — added _(2026-05-12)_ - `locations.research site|nanchang||china` — added _(2026-05-12)_ - `locations.research site|nanchong||china` — added _(2026-05-12)_ - `locations.research site|neijiang||china` — added _(2026-05-12)_ - `locations.research site|qiannan||china` — added _(2026-05-12)_ - `locations.research site|qujing||china` — added _(2026-05-12)_ - `locations.research site|sanmenxia||china` — added _(2026-05-12)_ - `locations.research site|shaoyang||china` — added _(2026-05-12)_ - `locations.research site|suzhou||china` — added _(2026-05-12)_ - `locations.research site|tengzhou||china` — added _(2026-05-12)_ - `locations.research site|tieling||china` — added _(2026-05-12)_ - `locations.research site|wenzhou||china` — added _(2026-05-12)_ - `locations.research site|xiangtan||china` — added _(2026-05-12)_ - `locations.research site|xiaogan||china` — added _(2026-05-12)_ - `locations.research site|xinyang||china` — added _(2026-05-12)_ - `locations.research site|yancheng||china` — added _(2026-05-12)_ - `locations.research site|yichang||china` — added _(2026-05-12)_ - `locations.research site|yuling||china` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06646419.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06646419* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*