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A multicenter randomized controlled study of Sequential OPEP with inhalation therapy medication in patients with pneumoconiosis

To evaluate the rehabilitation effect and safety of sequential OPEP inhalation in stable pneumoconiosis patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085581
Enrollment
Unknown
Registered
2024-06-12
Start date
2024-06-17
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

pneumoconiosis

Interventions

Experience group:Sequential OPEP inhaled medication
control group:Simple inhaled drug

Sponsors

Chengkou County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Signed written informed consent; (2) At least 18 years of age at the time of visit 1, but under 60 years of age; (3) For Stage II-III patients who meet the diagnostic criteria for pneumoconiosis, the diagnosis and grading of pneumoconiosis are based on GBZ70-2015 Diagnostic Criteria for Occupational Pneumoconiosis 1) One of the following manifestations is diagnosed as stage II pneumoconiosis: a) There is a small shadow of overall density level 2, distributed over 4 lung regions; b) There is a small shadow with an overall density of level 3, and the distribution range is up to 4 lung regions; c) Exposure to asbestos dust, with a small shadow of overall density 1, distributed over 4 lung areas, accompanied by pleural plaques that have involved part of the heart margin or diaphragmatic surface; d) Exposure to asbestos dust, with a small shadow of overall density of grade 2, distributed in 4 lung areas, accompanied by pleural plaques that have involved part of the heart border or diaphragmatic surface. 2) One of the following manifestations is diagnosed as pneumoconiosis: a) There is a large shadow, the long diameter is not less than 20mm, the short diameter is greater than 10mm; b) Small shadows of overall density level 3, distributed over 4 lung regions and with small shadow aggregation; c) Small shadows with an overall density of level 3, distributed over 4 lung regions and with large shadows; d) Exposure to asbestos dust, with a small shadow of overall density of grade 3, distributed over 4 lung areas, while the length of a single or multiple pleural spots on both sides exceeds half of the length of a single chest wall or involves the heart margin to make it partially disheveled. (4) must be able to use inhaled drugs correctly; (5) Can use OPEP trainer after instruction; (6) Female subjects must meet the following criteria to participate in the study: no potential fertility (i.e., no physical ability to conceive, including women who have been menopausal for 2 years) or no pregnancy plans; (7) The subject is willing and able to complete the follow-up according to the protocol; (8) The subject can cooperate to complete the relevant examination items; (9) Compliance: Subjects must be willing to return to the hospital for follow-up and complete all visit assessments according to the protocol. (1) Signed written informed consent; (2) At least 18 years of age at the time of visit 1, but under 60 years of age; (3) For Stage II-III patients who meet the diagnostic criteria for pneumoconiosis, the diagnosis and grading of pneumoconiosis are based on GBZ70-2015 Diagnostic Criteria for Occupational Pneumoconiosis [14] 1) One of the following manifestations is diagnosed as stage II pneumoconiosis: a) There is a small shadow of overall density level 2, distributed over 4 lung regions; b) There is a small shadow with an overall density of level 3, and the distribution range is up to 4 lung regions; c) Exposure to asbestos dust, with a small shadow of overall density 1, distributed over 4 lung areas, accompanied by pleural plaques that have involved part of the heart margin or diaphragmatic surface; d) Exposure to asbestos dust, with a small shadow of overall density of grade 2, distributed in 4 lung areas, accompanied by pleural plaques that have involved part of the heart border or diaphragmatic surface. 2) One of the following manifestations is diagnosed as pneumoconiosis: a) There is a large shadow, the long diameter is not less than 20mm, th

Exclusion criteria

Exclusion criteria: (1) Aggravation of the condition of the pneumoconiosis patient leading to change of medication or hospitalization within the past 4 weeks; (2) other respiratory diseases (active tuberculosis, severe pneumothorax, pulmonary bulla, severe pleural effusion, pulmonary embolism); (3) Severe primary diseases combined with other major organs or systems: Cancer (untreated tumors or the first two years of a tumor requiring treatment), Unexplained fever, unstable cardiovascular disease (arrhythmias (atrial flutter and fibrillation, frequent ventricular tachycardia, atrioventricular block) ischemic heart disease, myocardial infarction within the previous 6 months), uncontrolled hypertension (systolic blood pressure =160 mmHg, Diastolic blood pressure =90 mmHg)(1 mmHg=0.133 kPa), severe pulmonary hypertension, or accompanied by organ failure; (4) Evaluation and completion of a history of lung surgery, associated musculoskeletal disease, neurological disease, rheumatic connective tissue disease, systemic hematological system disease affecting recovery in the previous three months (presence of lumbar, back and/or limb dysfunction or postoperative status, severe arthritis or severe peripheral vascular disease, etc.); (5) Allergic to inhaled drugs; (6) previous history of syncope after exercise or contraindications; (7) People with mental disorders and cognitive disabilities; (8) Non-compliance: non-compliance with study procedures, including non-compliance with completion logs; (9) The validity of informed consent is in doubt: subjects with a history of mental illness, mental retardation, poor motivation, substance abuse (including drugs and alcohol), or other medical conditions that limit the validity of informed consent to participate in this study

Design outcomes

Primary

MeasureTime frame
6 minutes walking distance;Quality of Life Questionnaire (SGRQ);

Secondary

MeasureTime frame
Lung function;CAT score;Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ);Dyspnea Index Score (mMRC);Dyspnea, Cough and Sputum Scale (BCSS);

Countries

China

Contacts

Public ContactYuhua Meng

Chengkou County People's Hospital

1508234268@qq.com+86 138 9695 4560

Outcome results

None listed

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