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

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)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170429

Enrollment

160

Registered

2010-07-27

Start date

2010-07-31

Completion date

2011-02-28

Last updated

2010-07-27

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

Conditions

Cough Variant Asthma

Keywords

Cough Variant Asthma, Procaterol Hydrochloride

Brief summary

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

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.

Interventions

DRUGProcaterol hydrochloride

25µg BID for 8 weeks

DRUGMeptin placebo

25µg BID for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Patient cough symptom score	8 weeks
Therapy duration	8 weeks
Rates of adverse events	8 weeks

Secondary

Measure	Time frame
LCQ Life Quality Score	8 weeks

Countries

China

Contacts

Primary ContactXin Zhou

xzhou53@163.com0086-21-63240090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026