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

Overview

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 Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2011

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

  • Drug: Procaterol hydrochloride
    • 25µg BID for 8 weeks
  • Drug: Meptin placebo
    • 25µg BID for 8 weeks

Arms, Groups and Cohorts

  • Experimental: I. Procaterol Hydrochloride
    • Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
  • Placebo Comparator: II. Procaterol hydrochloride placebo
    • Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;

Clinical Trial Outcome Measures

Primary Measures

  • Patient cough symptom score
    • Time Frame: 8 weeks
  • Therapy duration
    • Time Frame: 8 weeks
  • Rates of adverse events
    • Time Frame: 8 weeks

Secondary Measures

  • LCQ Life Quality Score
    • Time Frame: 8 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Jiao Tong University School of Medicine
  • Provider of Information About this Clinical Study
    • Xin Zhou/Director of Respiratory Department, Shanghai Jiao Tong University Affiliated 1st People’s Hospital
  • Overall Official(s)
    • Xin Zhou, MD, Principal Investigator, Shanghai Jiao Tong University School of Medicine
  • Overall Contact(s)
    • Xin Zhou, 0086-21-63240090, xzhou53@163.com

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