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The purpose of this study is to investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (CVA).
This is a 8-week, double-blind, randomized, placebo-controlled study, the patients with CVA will be randomized to experimental or placebo control group.
During the screening period, eligible patients will be evaluated by cough symptom score and LCQ life quality score. After 4 and 8 weeks treatment, patients will be evaluated by cough symptom score and LCQ life quality score respectively. Adverse events will also be captured at every visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I. Procaterol Hydrochloride | Experimental | Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks; |
|
| II. Procaterol hydrochloride placebo | Placebo Comparator | Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procaterol hydrochloride | Drug | 25µg BID for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient cough symptom score | 8 weeks | |
| Therapy duration | 8 weeks | |
| Rates of adverse events | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LCQ Life Quality Score | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Zhou | Contact | 0086-21-63240090 | 3142 | xzhou53@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Zhou, MD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xin Zhou | Shanghai | Shanghai Municipality | 200080 | China |
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| ID | Term |
|---|---|
| D000096823 | Cough-Variant Asthma |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
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| ID | Term |
|---|---|
| D017265 | Procaterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Meptin placebo | Drug | 25µg BID for 8 weeks |
|
|
| D008171 |
| Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |