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A Randomized, Open-labeled, Parallel Controlled Study on the Efficacy and Safety of Combined Medication with Procaterol Hydrochloride and Montelukast in Treatment of Cough variant Asthma in Children.

A Randomized, Open-labeled, Parallel Controlled Study on the Efficacy and Safety of Combined Medication with Procaterol Hydrochloride and Montelukast in Treatment of Cough variant Asthma in Children.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012223
Enrollment
Unknown
Registered
2017-08-02
Start date
2013-06-30
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

Cough variant Asthma

Interventions

trial group:Procaterol Hydrochloride and Montelukast

Sponsors

Beijing Children’s Hospital ,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 2-14 yeas; 2. Physician -diagnosed cough-variant asthma from its symptoms and conditions;cough duration >4weeks,cough or with a white phlegm, cough as the main clinical symptoms or only symptoms, cough at night and (or )the early morning, cough will aggravate after exercise or contact with cold air, without wheeze and fever or antibiotic was ineffective after a long period treatment. 3.Chest X-ray:without obvious abnormalities; 4.Effective response to prior 3days diagnostic treatment with Procaterol. 5.Ask for the medical history in order to exclude postinfectious cough and UACS

Exclusion criteria

Exclusion criteria: 1. Patients are with heart, lung, liver, kidney and other organic disease; 2. Patients have history of upper respiratory tract infection, interstitial pneumonia, pulmonary tuberculosis and other medical diseases in the past 2 months; 3. Oral and inhaled corticosteroids were taken within the past 2 weeks; 4. Patients have participated in other clinical trials in the past 3 months; 5. Patients have adverse reactions to the study drugs; 6. Patients cannot comply with the study protocol; 7. Investigators judged patients who were not eligible for this clinical trials.

Design outcomes

Primary

MeasureTime frame
cough score;

Secondary

MeasureTime frame
LCQ questionnaire;Cough recurrence rate;Cough improvement rate;

Countries

China

Contacts

Public ContactZhang Yanhong

Zhejiang Otsuka Pharmaceutical Co., Ltd

zhangyh@zjotsuka.com+86 021 63527786

Outcome results

None listed

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