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Spirometry parameter in prediction of asthma diagnosis in patients with FEV1=70%: prospective, interventional, multi-center clinical study

Spirometry parameter in prediction of asthma diagnosis in patients with FEV1=70%: prospective, interventional, multi-center clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062053
Enrollment
Unknown
Registered
2022-07-21
Start date
2022-07-20
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Asthma

Interventions

all:BUD/FOR (160/4.5ug)1 PUFF 2/DAY

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, regardless of gender and race; 2. Recurrent episodes of symptom(wheezing, or shortness of breath, chest tightness, or coughing), symptoms present= 8 weeks; 3. FEV1 = 70%pred before BDTFVE1/FVC>0.7 after BDT; 4. No obvious abnormality in the blood routine except eosinophils and no obvious abnormality in the chest CT; 5. First clinic visit with newly presenting asthma-likely symptoms in 1 year; 6. Childbearing-age women taking effective contraceptive measures during the trial are considered; Agree to participate in this trial and be willing to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. No willingness for asthma test or due to other reasons. 2. Symptoms cause by respiratory infection within 4 weeks. 3. ACEI, ARB, and beta-blockers are under treatment. 4. Other chronic respiratory diseases such as COPD and interstitial pneumonia; serious comorbidity(e.g. cardiovascular, metabolic, immune, neurological, urinary, and hematological disease) may delay study conduction. 5. History of alcohol, narcotic drug abuse, mental illness, confrontational personality, bad motivation, paranoia, or another mental disease that may affect inform content evaluation in this study. 6. Current smoker; cessation smoking for less than 6 months; cessation smoking for more than 6 months but smoking more than 10 packs/year. 7. Participating in other drug clinical trials.

Design outcomes

Primary

MeasureTime frame
Forced expiratory volumone second(FEV1);Maximum Mid-Expiratory Flow(MMEF);asthma control test(ACT);Asthma Control Questionnaire-5(ACQ-5);Cough visual analogue scale(VAS) score;

Secondary

MeasureTime frame
peak expiratory flow(PEF);

Countries

China

Contacts

Public ContactMin Zhang
maggie_zhangmin@163.com+86 13482345145

Outcome results

None listed

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