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Pulmonary pharmacokinetics of inhaled budesonide suspension in patients with chronic obstructive pulmonary disease

Pulmonary pharmacokinetics of inhaled budesonide suspension in patients with chronic obstructive pulmonary disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103135
Enrollment
Unknown
Registered
2025-05-26
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

Trial group:none

Sponsors

Clinical Trial Center of Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Chronic obstructive pulmonary disease (COPD) patients >=18 years of age who meet the GOLD 2024 diagnostic criteria [GOLD 2024 criteria: patients with chronic respiratory symptoms such as dyspnoea, chronic cough or sputum and/or a history of exposure to risk factors, and pulmonary function tests showing: exertional expiratory volume in the first second after bronchodilator (FEV1)/exertional lung capacity (FVC) <0.7]; (2) Patients with a physician's diagnosis confirming the need for fibreoptic bronchoscopy and bronchoalveolar lavage during treatment; (3) Patients who are able to understand the nature, purpose, requirements, possible risks and adverse effects of the trial, and who have signed a written informed consent prior to the study.

Exclusion criteria

Exclusion criteria: (1) Subjects were excluded from the study for the presence of any of the following conditions: alpha-1 antitrypsin deficiency, asthma, active tuberculosis, pulmonary oedema, cystic fibrosis, occlusive bronchiectasis, tuberculosis (sarcoidosis), bronchiectasis, and unstable sleep apnoea; (2) Patients with haemosiderosis, needle-sickness, and a history of psychiatric and/or psychological disorders; (3) A history of pre-existing or current serious cardiovascular disease, including but not limited to: a. Signatory informed cardiac function class III/IV (based on New York Heart Association (NYHA) cardiac function classification); b. Acute myocardial infarction, unstable angina/acute coronary artery syndrome, percutaneous coronary intervention, coronary artery bypass grafting, within 6 months prior to signatory informed; c. Structural heart disease, e.g., hypertrophic cardiomyopathy, severe valvular disease; d. Structural heart disease, e.g., hypertrophic cardiomyopathy, severe valvular disease. heart disease such as hypertrophic cardiomyopathy, moderate to severe valvular disease; (4) Patients who are allergic to anaesthetics and who are unable to cooperate with fibrinoscopy; (5) Patients with uncontrollable bleeding due to severe coagulation disorders; (6) Patients at risk of rupture of aortic aneurysm; (7) Patients who have undergone pneumonectomy or who have undergone lung reduction surgery within 1 year prior to signing the PIC.

Design outcomes

Primary

MeasureTime frame
Concentration of budesonide in bronchoalveolar Lavage Fluid;Concentration of budesonide in plasma;

Countries

China

Contacts

Public ContactGuoping Yang

the Third Xiangya Hospital, Central South University

ygp9880@126.com+86 731 8991 8665

Outcome results

None listed

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