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A randomized, open-label, controlled, proof of concept trial to evaluate the efficacy of extra fine particle inhaled triple therapy in preventing progression to COPD in high-risk individuals with pre-COPD: a study protocol

A randomized, open-label, controlled, proof of concept trial to evaluate the efficacy of extra fine particle inhaled triple therapy in preventing progression to COPD in high-risk individuals with pre-COPD: a study protocol

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118322
Enrollment
Unknown
Registered
2026-02-04
Start date
2026-02-09
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Pro-COPD

Interventions

Treatment Group:Will receive Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide Inhalation Aerosol, 2 inhalations twice daily. The investigator will provide inhalation technique ed
Control Group:Will not receive inhaled medication, only conventional antitussive drugs.

Sponsors

Beijing General Aerospace Hospital (formerly the 731 Hospital of China Aerospace Science and Industry Corporation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 40 to 80 years old; Two of the three indicators, MMEF, FEF50%, and FEF75%, are less than 65%. 3. FEV1/FVC>=70%; 4. Those accompanied by one of the symptoms such as coughing, expectoration, or breathing difficulties; 5. No previous history of chronic obstructive pulmonary disease (COPD) or acute exacerbation of COPD; 6. There are no other imaging changes of lung diseases on CT scans, such as space-occupying lesions, exudations and interstitial changes. 7. No history of lung cancer, lobectomy or cystic fibrosis; 8. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have underlying lung diseases such as asthma, bronchiectasis and interstitial lung disease; 2. Have heart failure; 3. Are allergic to the study drug; 4. Do not wish to participate; 5. Pregnant; 6. Have other conditions that the researchers consider not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
The change value of pulmonary function (FEV1/FVC);

Secondary

MeasureTime frame
The change values of small airway function indicators (MMEF, FEF50%, FEF75%);The improvement of breathing difficulties symptoms;

Countries

China

Contacts

Public ContactYan Peng

Beijing General Aerospace Hospital (formerly the 731 Hospital of China Aerospace Science and Industry Corporation

yanpeng301@163.com+86 133 6694 1939

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026