Skip to content

Clinical Evaluation of the Therapeutic Efficacy of Fudosteine as an Adjunctive Treatment in Improving Small Airway Function in Patients with Chronic Obstructive Pulmonary Disease

Clinical Evaluation of the Therapeutic Efficacy of Fudosteine as an Adjunctive Treatment in Improving Small Airway Function in Patients with Chronic Obstructive Pulmonary Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125360
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Experiment group:Fudostatin Oral Solution

Sponsors

Subei People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1:   Age range: 40 - 80 years old. Gender: No restrictions; 2:   Patients with stable chronic obstructive pulmonary disease who meet the diagnostic criteria specified in the "Guidelines for Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease" (and who had no acute exacerbation within the previous 4 weeks before screening); 3:   The pulmonary function classification is at levels 1 to 3 of the GOLD system; 4:   There is dysfunction of the small airways (during screening, FEF25-75% was less than 65% of the predicted value); 5:   CAT score >= 10; 6:   Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1:   Those who are allergic to fudostatin or any of its components; 2:   Merge other diseases that severely affect lung function (such as bronchiectasis, asthma, pulmonary fibrosis, active tuberculosis of the lungs, lung cancer, etc.); 3:   Accompanied by severe dysfunction of the heart, liver and kidneys; 4:   Pregnant women, lactating women or those planning to become pregnant; 5:   Those who have participated in other drug clinical trials within the past three months; 6:   The researcher determined that there were no circumstances that would disqualify an individual from participating in this study.

Design outcomes

Primary

MeasureTime frame
FEF25-75%(Forced Expiratory Flow at 25–75% of Forced Vital Capacity);FEV1(Forced Expiratory Volume in 1 second);RV/TLC (Residual Volume / Total Lung Capacity);Modified Medical Research Council Dyspnea Scale;

Secondary

MeasureTime frame
Number of acute exacerbations;Quality of life score;

Countries

China

Contacts

Public ContactMin Lingfeng

Subei People's Hospital of Jiangsu province

minlingfeng@126.com+86 180 5106 1783

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026