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

July 26, 2010 updated by: Shanghai Jiao Tong University School of Medicine

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)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xin Zhou
  • Phone Number: 3142 0086-21-63240090
  • Email: xzhou53@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Xin Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
LCQ Life Quality Score
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Xin Zhou, MD, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 26, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002-ZOC-0902i

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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