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

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Cough Variant Asthma

Treatments: Drug: Meptin placebo; Drug: Procaterol hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01170429

002-ZOC-0902i

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

I. Procaterol Hydrochloride

Experimental group

Description:

Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;

Treatment:

Drug: Procaterol hydrochloride

II. Procaterol hydrochloride placebo

Placebo Comparator group

Description:

Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;

Treatment:

Drug: Meptin placebo