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The efficacy of budesonide/formoterol in cough variant asthma: A Multi-center Randomized, Controlled Clinical Trial

The efficacy of budesonide/formoterol in cough variant asthma: A Multi-center Randomized, Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019852
Enrollment
Unknown
Registered
2018-12-02
Start date
2018-12-05
Completion date
Unknown
Last updated
2018-12-04

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

Conditions

cough variant asthma

Interventions

Group 1:budesonide/formoterol (Symbicort) 160/4.5ug 2 inhalation bid* 3 months
Group 2:budesonide/formoterol (Symbicort) 160/4.5ug 1 inhalation bid* 3 months

Sponsors

Second Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign and date the informed consent form indicating that they understand the purpose of and procedure required for the study and are willing to participate in the study; 2. Outpatients aged 18 to 70 years old; 3. Newly diagnosed as CVA, based on symptom and confirm by pulmonary function test according to China asthma guideline 2016 and China cough guideline (2015). Chronic cough(=8 weeks) without wheeze symptoms and signs, often worse at night and (or) in the early morning, often triggered by exercise. Pulmonary function test must meet one of the following three, suggesting a variable airflow limitation and as a basis for lung function diagnosis of asthma: 1) Positive of bronchial challenge test; 2) Positive of bronchodilation test (both FEV1 increased> 12% and FEV1 absolute increase> 200 ml after inhalation of bronchodilator); 3) Excessive variability in twice-daily PEF over 2 weeks: average daily diurnal PEF variability>10%, or average weekly diurnal PEF variability>20%; 4. CSS (cough symptom score, daytime + nighttime) = 3 points.

Exclusion criteria

Exclusion criteria: 1. Participated in any interventional clinical trial during the last 90 days; 2. Accompany with pregnancy; 3. Associated with a clear history of lung diseases such as COPD, bronchiectasis, pulmonary infection, pulmonary interstitial disease, pulmonary hypertension, etc; Or combined with other systems severe illness like cardiovascular, metabolic, immunological, neurological, urinary and blood diseases which may affect the normal conduct of this study; 4.An abuse history of alcohol or narcotic drug, or have a mental history, confrontation personality, adverse motives, suspicious or other emotional or intellectual problems that may affect the informed validity of the study; 5. With a history of upper respiratory tract infection acute exacerbation within 4 weeks before enrollment; 6. Clinical abnormalities associated with symptoms in chest radiology; 7. Smokers; 8. On medications of ACEI or ARB; 9. Not suitable for study observation judged by investigators.

Design outcomes

Secondary

MeasureTime frame
proportion of CVA patient with symptom relief;

Primary

MeasureTime frame
proportion of CVA patient with symptom relapse;

Countries

China

Contacts

Public ContactWen Li

Second Affiliated Hospital, Zhejiang University School of Medicine

liwenzjhz0408@163.com+86 13634113988

Outcome results

None listed

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