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Clinical Study on Pre-discharge Pulmonary Rehabilitation and Optimized Inhalation Therapy Management for Patients with Exacerbation of Chronic Obstructive Pulmonary Disease: a multi-center, prospective, non-blinded, randomized controlled clinical study

Clinical Study on Pre-discharge Pulmonary Rehabilitation and Optimized Inhalation Therapy Management for Patients with Exacerbation of Chronic Obstructive Pulmonary Disease: a multi-center, prospective, non-blinded, randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103554
Enrollment
Unknown
Registered
2025-05-30
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease

Interventions

Intervention Group:Device selection is guided by PIFr measurements. Pre-prescription on-site training is provided to evaluate inhaler competency, with daily technique verification (>= 3 times/day). Ea
Routine Care Group :The Routine Care Group received treatment and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 Report.

Sponsors

Zhongshan hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Peri-discharge Period: Hospitalized for an acute exacerbation of COPD (AECOPD) and now in the recovery phase (peri-discharge period), meeting the 2024 GOLD guideline definitions for: COPD: Post-bronchodilator FEV1/FVC = 10. 4.Exacerbation History: At least 2 moderate exacerbations or 1 severe exacerbation in the past year. 5.Informed Consent: Ability to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Stable COPD: Patients in the stable phase of COPD (where symptoms such as cough, sputum, and shortness of breath are stable or mild, and the condition has essentially returned to the pre-exacerbation state). 2.Requirement/Contraindication for Long-Term Corticosteroid Therapy: Presence of comorbidities requiring or contraindicated for long-term corticosteroid therapy, such as asthma, interstitial lung disease, sarcoidosis, cystic fibrosis, active pulmonary tuberculosis, recurrent aspiration pneumonia, etc. 3.Severe Life-Threatening Comorbidities: Presence of severe comorbidities posing an immediate threat to life, with an expected survival of less than 1 year (e.g., severe heart disease, severe chronic liver disease, severe kidney disease, chronic cerebrovascular disease requiring prolonged bed rest, malignancy, etc.). 4.Pregnancy or Lactation: Women who are pregnant or breastfeeding. 5.Current Participation in Other Interventional Studies: Patients currently participating in any other interventional clinical trial or study. 6.Lack of Legal Capacity: Patients who lack legal capacity or whose legal capacity is limited. 7.Investigator Discretion: Any other condition that, in the judgment of the investigator, makes the patient unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Treatment Failure;

Secondary

MeasureTime frame
Clinically Important Deterioration (CID);Treatment compliance;treatment Satisfaction ;

Countries

China

Contacts

Public ContactJing Zhang

Zhongshan hospital, Fudan University

zhang.jing@zs-hospital.sh.cn+86 182 1776 3953

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026