Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Multicentered, Double-blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Procaterol Hydrochloride With Inhaled Glucocorticoid in Treatment Patients With Cough Variant Asthma (CVA)

Conditions
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Cough Variant Asthma

Intervention / Treatment
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* Drug: Procaterol hydrochloride
* Drug: Meptin placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female patients,18-75 years old; cough lasting over 3 weeks ; dry cough or with slight white mucous phlegm; cough is the main clinical symptom or the only symptom; without wheeze and fever; without the history of upper respiratory tract infection within recent two months; non-smoking or giving-up smoking for over two years; without rales from lung; no obvious abnormalities from chest X-ray; bronchial provocation test: positive. Exclusion Criteria: patients with chronic pulmonary disease; patients who are allergic to ß2 receptor agonist; patients taking ß2 receptor agonist for long time; severe heart, renal and hepatic disease; unable to comply with the protocol; pregnant, breast feeding, and childbearing potential women; patients improper to the trial according to the investigators' judgment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I. Procaterol Hydrochloride<br>Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks; | Drug: Procaterol hydrochloride<br>* 25µg BID for 8 weeks<br>* Other names: Meptin;|
| Placebo Comparator: II. Procaterol hydrochloride placebo<br>Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks; | Drug: Meptin placebo<br>* 25µg BID for 8 weeks<br>* Other names: Meptin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient cough symptom score |  | 8 weeks | 
| Therapy duration |  | 8 weeks | 
| Rates of adverse events |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LCQ Life Quality Score |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cough Variant Asthma, Procaterol Hydrochloride