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Efficacy and safety of a double dose fine pariticles or replacement of ultrafine particles (low or medium doses) in patients with mild to moderate asthma with poor efficacy of low-dose fine-particle ICS/LABA and/or unameliorated small-airway dysfunction

The efficacy and safety of ultrafine/fine-particle ICS combined with LABA in patients with normal FEV1 asthma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045663
Enrollment
Unknown
Registered
2021-04-20
Start date
2021-04-20
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

asthma

Interventions

low dose ultra-fine particles group:beclomethasone formoterol (100/6ug, one dose twice a day)
medium dose ultra-fine particles group:beclomethasone formoterol (100/6ug, double dose twice a day)
medium dose fine particles group:budesonide formoterol (320ug/9ug,one dose twice a day)

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and <= 70 years; 2. With recurrent cough, chest tightness or wheezing symptoms; ACT is less than 20 points; 3. Positive provocation test, positive diastolic test, or 12% improvement of FEV1 by inhaled hormone therapy, 200mL; 4. Regular use of budesonide formoterol (160ug/4.5ug, 1 puff, bid) for more than 2 months still can not get a significant improvement in wheezing, chest tightness and/or cough symptoms.

Exclusion criteria

Exclusion criteria: 1. Body temperature exceeds 37.5 degree or abnormal blood picture (white blood cell count >1.0x10^9/L or < 0.4x10^9/L); 2. Combined with obvious cystic or columnar bronchiectasis, lung infection or interstitial pneumonia; History of respiratory infection within 3.4 weeks; 4. Smoking history, more than 100 years; 5. History of lung surgery.

Design outcomes

Primary

MeasureTime frame
Lung function;

Countries

China

Contacts

Public ContactBao Wuping

Shanghai Gengeral Hospital

wupingbao1982@163.com+86 13641688269

Outcome results

None listed

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