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

Primary Purpose

Cough Variant Asthma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Procaterol hydrochloride
Meptin placebo
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough Variant Asthma focused on measuring Cough Variant Asthma, Procaterol Hydrochloride

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xin Zhou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

I. Procaterol Hydrochloride

II. Procaterol hydrochloride placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patient cough symptom score
Therapy duration
Rates of adverse events

Secondary Outcome Measures

LCQ Life Quality Score

Full Information

First Posted
July 23, 2010
Last Updated
July 26, 2010
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01170429
Brief Title
Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)
Official Title
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
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough Variant Asthma
Keywords
Cough Variant Asthma, Procaterol Hydrochloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I. Procaterol Hydrochloride
Arm Type
Experimental
Arm Description
Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
Arm Title
II. Procaterol hydrochloride placebo
Arm Type
Placebo Comparator
Arm Description
Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
Intervention Type
Drug
Intervention Name(s)
Procaterol hydrochloride
Other Intervention Name(s)
Meptin
Intervention Description
25µg BID for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Meptin placebo
Other Intervention Name(s)
Meptin
Intervention Description
25µg BID for 8 weeks
Primary Outcome Measure Information:
Title
Patient cough symptom score
Time Frame
8 weeks
Title
Therapy duration
Time Frame
8 weeks
Title
Rates of adverse events
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
LCQ Life Quality Score
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Zhou
Phone
0086-21-63240090
Ext
3142
Email
xzhou53@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Zhou, MD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xin Zhou
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China

12. IPD Sharing Statement

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

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