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Evaluation of the curative effect of double bronchodilators in the treatment of pneumoconiosis patients with ventilatory dysfunction

Evaluation of the curative effect of double bronchodilators in the treatment of pneumoconiosis patients with ventilatory dysfunction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057201
Enrollment
Unknown
Registered
2022-03-03
Start date
2022-02-23
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

pneumoconiosis

Interventions

Control group:Conventional treatment and placebo
Experimental group:Conventional treatment + double bronchodilator

Sponsors

The 920th Hospital of the Joint Logistics Support Force of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. According to the diagnosis of occupational pneumoconiosis in China (GBZ 70 -- 2015), the patient was diagnosed as pneumoconiosis; 2. Pulmonary function showed patients with ventilation dysfunction, that is, pulmonary function tests suggested (FEVl >= 50%, but =60 mL/ year); 3. mMRC Dyspnea Scale 1 - 2; 4. Aged 18-80 years, agree to participate in this research.

Exclusion criteria

Exclusion criteria: 1. Asthma, long-term use of hormones, allergy to ummeteronium/vilanterol; 2. Patients with acute myocardial infarction or NYHA class IV; 3. After disease control, bronchodilator should be stopped for <=4 weeks; 4. Patients with malignant tumors and severe systemic diseases who cannot complete the treatment; 5. Special population: severe mental abnormality cannot cooperate with patients and pregnant patients.

Design outcomes

Primary

MeasureTime frame
forced expiratory volume in 1st second;

Secondary

MeasureTime frame
lung capacity;forced vital capacity;1 second rate;peak expiratory flow;maximum expiratory 25% vital capacity instantaneous flow;maximum expiratory 50% vital capacity instantaneous flow;maximum expiratory 75% vital capacity instantaneous flow;maximum mid-expiratory flow;questionnaire survey data;

Countries

China

Contacts

Public ContactLi Shaoying
1024942115@qq.com+86 13320507969

Outcome results

None listed

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