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

NCT ID: NCT01170429

Last Updated: 2010-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-02-28

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.

Conditions

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Cough Variant Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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I. Procaterol Hydrochloride

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

Group Type EXPERIMENTAL

Procaterol hydrochloride

Intervention Type DRUG

25µg BID for 8 weeks

II. Procaterol hydrochloride placebo

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

Group Type PLACEBO_COMPARATOR

Meptin placebo

Intervention Type DRUG

25µg BID for 8 weeks

Interventions

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Procaterol hydrochloride

25µg BID for 8 weeks

Intervention Type DRUG

Meptin placebo

25µg BID for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Meptin Meptin

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Shanghai Jiao Tong University Affiliated 1st People's Hospital

Principal Investigators

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Xin Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Xin Zhou

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xin Zhou

Role: CONTACT

0086-21-63240090 ext. 3142

Other Identifiers

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002-ZOC-0902i

Identifier Type: -

Identifier Source: org_study_id

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