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

Cough Variant Asthma Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01170429
• Other study ID #: 002-ZOC-0902i
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 23, 2010
• Last updated: July 26, 2010
• Start date: July 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2010
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Xin Zhou
• Phone: 0086-21-63240090
• Email: xzhou53[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Cough
• Cough Variant Asthma

Intervention

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

Locations

Country	Name	City	State
China	Xin Zhou	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient cough symptom score		8 weeks	No
Primary	Therapy duration		8 weeks	No
Primary	Rates of adverse events		8 weeks	Yes
Secondary	LCQ Life Quality Score		8 weeks	No